Cancer Research in HKUMed
4. Lung

4.0 Lung

4.1 Clinical Trial

4.1.1 Non-Small Cell Lung Cancer (NSCLC)

4.1.1.1 Oncogenic Driver Mutation

4.1.1.1.1.1 EGFR mutation

Locally Advanced or Metastatic

Second-line or Subsequent treatment (Previously treated, failure to EGFR-TKI):

Phase 3

Targeted Therapy (Anti-HER3 ADC)

HERTHENA-Lung02 (Protocol ID: U31402-A-U301): A phase 3, randomized, open-label study of patritumab deruxtecan versus platinum-based chemotherapy in metastatic or locally advanced EGFR-mutated NSCLC after failure of EGFR tyrosine kinase inhibitor (TKI) therapy.

(This study expects recruitment completion in Nov/Dec 2023).

Key Inclusion Criteria:

1. Patients with EGFR-activating mutation (exon 19 deletion or L858R).

    

2. Previously received 1 or 2 prior line(s) of EGFR TKI treatment and progressed.

Key Exclusion Criteria:

1. Histologically squamous/mixed NSCLC.

    

2. Clinically active CNS metastasis.

Patritumab Deruxtecan (U3-1402; HER3-DXd) (Anti-HER3 Antibody Drug Conjugate)

Vs.

Carbo/Cis-platin + Pemetrexed (Chemo)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.1.1.2 EGFR, MET mutation

Locally Advanced or Metastatic

Second or Third-line treatment: Phase 3

Targeted therapy (EGFR/ MET Inhibitor)

SAFFRON (Protocol ID: D5087C00001):

A phase 3, randomized, open-label study of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated MET-positive, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.

Key Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.

    

2. Patients with EGFR-activating mutation (exon 19 deletion, L858R and/or T790M).

    

3. Previously received 1 or 2 prior line(s) of EGFR TKI treatment and progressed.

    

4. MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.

Key Exclusion Criteria:

1. Prior or current treatment with a third-generation EGFR-TKI other than osimertinib.

    

2. Prior or current treatment with savolitinib or another MET inhibitors.

Osimertinib (EGFR inhibitor) + savolitinib (MET inhibitor)

Vs.

Carbo/Cis-platin + Pemetrexed (Chemo)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.1.1.3 EGFR mutation

Early and Locally Advanced (Stage II – Stage IIIB), Resectable

Adjuvant treatment: Phase 2

Targeted Therapy (EGFR inhibitor)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

TARGET (Protocol ID: D5162C00048):

An open-label, single-arm, phase 2, multinational, multicentre study to assess the efficacy and safety of 5 years of osimertinib in participants with epidermal growth factor receptor mutation-positive stage II-IIIB non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy.

Key Inclusion Criteria:

1. Histologically confirmed diagnosis of primary NSCLC on predominantly non-squamous histology.

    

2. Participants must be classified post-operatively as Stage II, IIIA, or IIIB on the basis of surgical pathologic criteria.

    

3. Confirmation by the local laboratory that the tumour harbours one of the two common EGFR mutations (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo EGFR mutation resulting in substitution of threonine with methionine at amino acid position 790 in exon 20 of EGFR (T790M) or uncommon EGFR mutations G719X, S768I, and L861Q, either alone, in combination with each other, or in combination with other uncommon EGFR mutations (excluding all exon 20 insertions) (Uncommon EGFR Cohort).

Key Exclusion Criteria:

1. Histologically squamous/mixed NSCLC.

    

2. Active Hepatitis B/C or HIV infection.

Osimertinib (EGFR inhibitor)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.1.1.4 EGFR mutation

Locally Advanced or Metastatic

First-line treatment: Phase 2

Targeted Therapy (EGFR inhibitor/ EGFR+MET antibody)

OSTARA (Protocol ID: D5162C00052):

A phase 2, open-label, single-arm, multi-centre study to evaluate the safety and efficacy of osimertinib with amivantamab as first-line treatment in participants with epidermal growth factor receptor mutation-positive, locally advanced or metastatic Non-Small-Cell Lung Cancer.

(Wave 1 cohort will be ended soon. The "wave 2" cohort will be opened in early 2024)

Key Inclusion Criteria:

1. Histologically or cytologically documented non-squamous NSCLC. NSCLC of mixed histology is allowed.

    

2. Newly diagnosed locally advanced or metastatic NSCLC or recurrent non-squamous NSCLC, not amenable to curative surgery or radiotherapy.

    

3. Tumour harbours one of the 2 common EGFRm known to be associated with EGFR-TKI sensitivity.

Key Exclusion Criteria:

1. Histologically squamous/mixed NSCLC.

    

2. Clinically active CNS metastasis.

    

3. History of interstitial lung disease (ILD).

Osimertinib (EGFR inhibitor) (oral)

+ amivantamab (bispecific anti-EGFR + MET antibody) (IV)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.1.1.5 EGFR, ALK, or ROS1 mutation

Metastatic (Stage IV)

Second-line treatment: Phase 2

Immunotherapy (Anti-PD-1), Targeted therapy (VEGFR inhibitor), Chemotherapy

A Phase 2 Open-label Single-arm Study to Evaluate the Combination of pembrolizumab, lenvatinib and Chemotherapy in Non-small Cell Lung Cancer (NSCLC) Harbouring Targetable Mutation and Failed Standard Tyrosine Kinase Inhibitors.

Key Inclusion Criteria:

1. Histologically proven NSCLC.

    

2. Unresectable or metastatic NSCLC.

    

3. Harboring sensitizing EGFR, ALK, or ROS1 genetic aberrations who have received standard of care targeted therapy and have progressed on treatment. Patients with known T790M mutation should have received osimertinib and failed.

Pembrolizumab + lenvatinib (VEGFR Inhibitor) + Pemetrexed + Carboplatin

Dr. Joanne Chiu

Department of Medicine (Medical Oncology)

jwychiu@hku.hk

2255 5582

4.1.1.1.1.6 EGFR mutation

Locally Advanced or Metastatic

Second-line or Subsequent-line treatment (Previously treated, failure to platinum based chemotherapy and/or EGFR-TKIs): Phase 1/2a

Targeted therapy (EGFR inhibitor)

REZILIENT1 (Protocol ID: CLN-081-001):

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Key Inclusion Criteria:

1. Documented EGFR exon 20 insertion mutation demonstrated by a test routinely used by each institution and performed in a CLIA-certified or equivalent laboratory.

    

2. Prior treatment in the recurrent/metastatic disease setting including:

• A platinum-based chemotherapy regimen (or other chemotherapy regimen if platinum-based chemotherapy is contra-indicated).

   

• Any other approved standard therapy that is available to the patient, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. In the case of a patient declining such therapy, documentation that the patient has been informed and declined should be documented in the medical record.

CLN-081 (EGFR Inhibitor)

Dr. Victor Lee

Department of Clinical Oncology

vhflee@hku.hk

Mike LAW

2255 5124

4.1.1.1 Oncogenic Driver Mutation

4.1.1.1.4.1 KRAS mutation

Advanced or Metastatic

Second-line treatment: Phase 2/3

Targeted therapy (KRAS G12C inhibitor)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

B-FAST (Blood-First Assay Screening Trial, Protocol ID: BO29554, Cohort G):

A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood.

Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC.

    

2. Locally advanced or metastatic NSCLC with K-RAS G12C mutation.

Key Exclusion Criteria:

1. Clinically active CNS metastasis

    

2. Inability to swallow oral medication

    

3. Known HIV infection.

GDC-6036 (KRAS G12C Inhibitor: Divarasib)

Vs.

Docetaxel (Chemo)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.1 Oncogenic Driver Mutation

4.1.1.1.5.1 HER2 mutation

Advanced or Metastatic

First or Subsequent-line treatment: Phase 1

Targeted Therapy (HER2 TKI Inhibitor)

BEAMION-Lung1 (Protocol ID: 1479-0001):

An open label, phase 1 dose escalation trial, with dose confirmation and expansion, of BI1810631 as monotherapy in patients with advanced or metastatic solid tumours with HER2 aberrations.

Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-haematologic malignancy.

    

2. Treatment naïve or previously treated locally advanced or metastatic NSCLC patients with HER mutation (with multiple cohort groups in this study).

Key Exclusion Criteria:

1. Clinically active CNS metastasis.

    

2. Active Hepatitis B/C or HIV infection.

BI 1810631 (Anti HER-2 inhibitor)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.1.5.2 HER2 mutation and/or EGFR

Locally Advanced or Metastatic

Second-line or Subsequent-line treatment: Phase 1

Targeted therapy (EGFR/ HER2 inhibitor)

BAYER21607 (Protocol ID: 21607):

An open label, first-in-human study of BAY2927088 in participants with advanced non-small cell lung cancer (NSCLC) harboring an EGFR and/or HER2 mutation.

(only competitive HER2 cohorts available in this study)

Key Inclusion Criteria:

1. Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).

    

2. Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.

    

3. Documented activating EGFR and/or HER2 mutation.

BAY2927088 (EGFR and HER2 Inhibitor)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.1 Oncogenic Driver Mutation

4.1.1.1.6.1 MET, EGFR mutation (same as study: 4.1.1.1.1.3)

Locally Advanced or Metastatic

Second or Third-line treatment: Phase 3

Targeted therapy (EGFR/ MET Inhibitor)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

SAFFRON (Protocol ID: D5087C00001):

A phase 3, randomized, open-label study of savolitinib in combination with osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated MET-positive, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.

Key Inclusion Criteria:

1. Histologically or cytologically confirmed locally advanced or metastatic NSCLC which is not amenable to curative therapy.

    

2. Patients with EGFR-activating mutation (exon 19 deletion, L858R and/or T790M).

    

3. Previously received 1 or 2 prior line(s) of EGFR TKI treatment and progressed.

    

4. MET overexpression and/or amplification in tumour specimen collected following progression on prior osimertinib treatment.

Key Exclusion Criteria:

1. Prior or current treatment with a third-generation EGFR-TKI other than osimertinib.

    

2. Prior or current treatment with savolitinib or another MET inhibitor.

Osimertinib (EGFR inhibitor) + savolitinib (MET inhibitor)

Vs.

Carbo/Cis-platin + Pemetrexed (Chemo)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1 NSCLC

4.1.1.2 Wildtype

4.1.1.2.1.1 PD-L1 High (≥50%)

Locally Advanced or Metastatic

First-line treatment: Phase 3

Immunotherapy (Anti-PD-1 Antibody), Chemotherapy

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

ARC-10 (Protocol ID: 2020-003562-39):

A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined with Domvanalimab (AB154) Conpared to Pembrolizumab in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Key Inclusion Criteria:

1. Histologically confirmed, treatment naïve, locally advanced or metastatic (Stage IIIB - IV), squamous or non-squamous NSCLC with documented high PD-L1 Expression.

    

2. If a participant has brain or meningeal metastases, the participant must meet the following criteria:

• Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose.

   

• Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment. Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted.

   

• Carcinomatous meningitis is excluded regardless of clinical stability.

Zimberelimab (AB122)

+

Domvanalimab (AB154)

vs

Pembrolizumab

Dr. Victor Lee

Department of Clinical Oncology

vhflee@hku.hk

Angela IU

2255 5124

4.1.1 NSCLC

4.1.1.2 Wildtype

4.1.1.2.3.1 PD-L1 ≥1%

Metastatic (Stage IV)

First-line treatment: Phase 3

Immunotherapy (Anti-TIGIT antibody, Anti-PD-1 antibody)

KEYVIBE-003 (Protocol ID: MK-7684A-003):

A Phase 3, Multicenter, Randomized, Double-Blind Study of MK-7684 with pembrolizumab as a Coformulation (MK-7684A) Versus pembrolizumab Monotherapy as First Line Treatment for Participants With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer.

Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of Stage IV.

    

2. Epidermal growth factor receptor (EGFR)-, anaplastic lymphoma kinase (ALK)-, or reactive oxygen species proto-oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy.

    

3. Programmed Cell Death 1 Ligand 1 (PD-L1) expression in ≥1% of tumor cells.

MK-7684A

(Vibostolimab (Anti-TIGIT Monoclonal antibody) + pembrolizumab (Anti-PD-1 monoclonal antibody))

Dr. Joanne Chiu

Department of Medicine (Medical Oncology)

jwychiu@hku.hk

2255 5582

4.1.1 NSCLC

4.1.1.2 Wildtype

4.1.1.2.4.1 PD-L1 all comers

Metastatic (Stage IV)

First-line treatment: Phase 3

Immunotherapy (Anti-PD-1/ Anti-TIGIT Antibody), Chemotherapy

STAR-121 (Protocol ID: GS-US-626-6216):

A randomized, open-label, phase 3 study to evaluate zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy for the first-line treatment of patients with metastatic non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.

Key Inclusion Criteria:

1. Both adeno- and squamous NSCLC treatment naïve patients without known genomic alternation (including ALK and EGFR).

Key Exclusion Criteria:

1. Histologically SCLC/mixed NSCLC.

    

2. Clinically active CNS metastases.

    

3. Previously treated with PD-(L)1 immune checkpoint antibody/-ies.

Zimberelimab (Anti-PD-1 Antibody) and domvanalimab (Anti-TIGIT Antibody) + Chemotherapy (Carbo/cisplatin + Pemetrexed/Paclitaxel)

Vs.

Zimberelimab (Anti-PD-1 Antibody) + Chemo-therapy

Vs.

Pembrolizumab (Anti-PD-1 Antibody) + Chemotherapy

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.2.4.2 PD-L1 all comers (same study as 4.1.1.2.4.1)

Metastatic (Stage IV)

First-line treatment: Phase 3

Immunotherapy (Anti-PD-1/ Anti-TIGIT Antibody), Chemotherapy

STAR-121 (Protocol ID: GS-US-626-6216):

A randomized, open-label, phase 3 study to evaluate zimberelimab and domvanalimab in combination with chemotherapy versus pembrolizumab with chemotherapy for the first-line treatment of patients with metastatic non-small cell lung cancer with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations.

Key Inclusion Criteria:

1. Both adeno- and squamous NSCLC treatment naïve patients without known genomic alternation (including ALK and EGFR).

Key Exclusion Criteria:

1. Histologically SCLC/mixed NSCLC.

    

2. Clinically active CNS metastases.

    

3. Previously treated with PD-(L)1 immune checkpoint antibody/-ies.

Zimberelimab (Anti-PD-1 Antibody) and domvanalimab (Anti-TIGIT Antibody) + Chemotherapy (Carbo/cisplatin + Pemetrexed/Paclitaxel)

Vs.

Zimberelimab (Anti-PD-1 Antibody) + Chemo-therapy

Vs.

Pembrolizumab (Anti-PD-1 Antibody) + Chemotherapy

Dr. Victor LEE

Department of Clinical Oncology

vhflee@hku.hk

Angela IU

2255 5124

4.1.1.2.4.3 PD-L1 all comers

Locally Advanced or Metastatic

Second-line or Third-line treatment: Phase 3

Targeted therapy (ATR Kinase Inhibitor), Immunotherapy (Anti-PD-L1 Antibody), Chemotherapy

LATIFY (Protocol ID: D533BC00001):

A phase 3, open-label, randomized, multicenter study of Ceralasertib plus durvalumab versus docetaxel in patients with advanced or metastatic non-small cell lung cancer whose disease has progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy

Key Inclusion Criteria:

1. Both adeno- and squamous locally advanced or metastatic NSCLC patients.

    

2. Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.

    

3. Must previously treated with PD-(L)1 antibody and platinum doublet containing therapy in their 1 or 2 prior line(s) treatment and progressed.

Key Exclusion Criteria:

1. Histologically SCLC/mixed NSCLC.

    

2. Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.

    

3. Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.

    

4. Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

Ceralasertib (Oral) (ATR Kinase Inhibitor)

+ durvalumab (IV) (Anti-PD-L1 Antibody)

Vs.

Docetaxel (Chemo)

Dr. James Chung Man Ho

Department of Medicine

jhocm@hku.hk

2255 4349

4.1.1.2.4.4 PD-L1 all comers

Metastatic (Stage IV)

First-line treatment: Phase 2

Targeted Therapy (Anti-Trop2-ADC)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

EVOKE-02 (Protocol ID: GS-US-576-6220):

An Open-label, Multicenter, Phase 2 Study of Sacituzumab Govitecan Combinations in First-line Treatment of Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) Without Actionable Genomic Alterations.

Key Inclusion Criteria:

1. Pathologically documented evidence of Stage IV non-small cell lung Cancer.

    

2. No prior systemic treatment for metastatic NSCLC.

Sacituzumab Govitecan-hziy (Antibody Drug Conjugate) + Pembrolizumab (Anti-PD-1 monoclonal antibody)

Vs.

SG + Pembrolizumab + Carboplatin(Chemo)

Vs.

SG + Pembrolizumab + Cisplatin

Dr. Joanne Chiu

Department of Medicine (Medical Oncology)

jwychiu@hku.hk

2255 5582

4.1.1.2.4.5 PD-L1 all comers

Locally Advanced or Metastatic

Second-line or Subsequent-line treatment: Phase 2

Targeted therapy (Anti-AXL ADC), Immunotherapy (PD-1 inhibitor)

A phase 2 study of BA3011 alone and in combination with PD-1 inhibitor in adult patients with metastatic non-small cell lung cancer (NSCLC) who had prior disease progression on a PD-1/L-1 inhibitor.

Key Inclusion Criteria:

1. Have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC.

1. Have prior disease progression on or after receiving an approved PD-1/L1, EGFR or ALK inhibitor (either monotherapy or in combination with another therapy).

BA3011 (Antibody-drug conjugate (ADC))

Vs.

BA3011 (Antibody-drug conjugate (ADC))

+ PD-1 inhibitor

Dr. Thomas Yau

Department of Medicine (Medical Oncology)

medicaloncology@hku.hk

2255 5582

4.1.1.2.4.6 PD-L1 all comers

Locally Advanced or Metastatic

Second-line or Subsequent-line treatment: Phase 2

Targeted Therapy: (Anti-HRS7-SN38 ADC)

TROPiCS-03 (Protocol ID: IMMU-132-11):

A phase 2, open-label study of sacituzumab govitecan (IMMU-132) in subjects with metastatic solid tumours.

Key Inclusion Criteria:

1. Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors:

• Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy. No more than 3 prior lines of systemic treatment is allowed.

   

• NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy.

   

• HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.

   

• Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed).

Key Exclusion Criteria:

1. Have had a prior anti-cancer biologic agent within the 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.

    

2. Have not recovered (i.e., ≤ Grade 1) from AEs caused by a previously administered agent.

    

3. Have previously received topoisomerase I inhibitors (for SCLC cohort: Etoposide with platinum combination in first-line setting is allowed).

Sacituzumab Govitecan (Anti-HRS7-SN38 ADC)

Dr. Roland Leung

Department of Obstetrics & Gynaecology

tseky@hku.hk

Dr. Ka Yu Tse

2255 5102 9061 9609

4.0 Lung

4.1 Clinical Trial

4.1.2 SCLC

Locally Advanced or Metastatic

Specific Selection Criteria: Progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy

Second-line treatment: Phase 2

Targeted Therapy: (Anti-HRS7-SN38 ADC)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

TROPiCS-03 (Protocol ID: IMMU-132-11):

A phase 2, open-label study of sacituzumab govitecan (IMMU-132) in subjects with metastatic solid tumours.

Key Inclusion Criteria:

1. Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors:

• Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy. No more than 3 prior lines of systemic treatment is allowed.

   

• NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD-(L)1) directed therapy.

   

• HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy No more than 3 prior lines of systemic treatment is allowed.

   

• Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed).

Key Exclusion Criteria:

1. Have had a prior anti-cancer biologic agent within the 4 weeks prior to Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1.

    

2. Have not recovered (i.e., ≤ Grade 1) from AEs caused by a previously administered agent.

    

3. Have previously received topoisomerase I inhibitors (for SCLC cohort: Etoposide with platinum combination in first-line setting is allowed).

Sacituzumab Govitecan (Anti-HRS7-SN38 ADC)

Dr. Ka Yu Tse

Department of Obstetrics & Gynaecology

tseky@hku.hk

Dr. Ka Yu Tse

2255 5102

9061 9609

4.0 Lung

4.2.1 Supportive Cancer Care

Early Stage (Resectable)

Study Title

Main Inclusion/Exclusion

Principal Investigator

Department

Email

Contact number

A rehabilitation Program to Boost Postoperative Functional Capacity in Surgical Lung Cancer Patients: A Randomized Controlled Trial.

Key Inclusion Criteria:

1. Suspected or confirmed stage I, II, or IIIA NSCLC diagnosis

    

2. Scheduled to undergo lung section ≥2 weeks from commencement of the first intervention class

    

3. Engagement in less than 150 minutes of moderate aerobic activity per week in the past 3 months.

    

4. 6MWT <500 meters at baseline

    

5. No evidence of recurrent or progressive disease.

    

6. Aged 45–80.

Key Exclusion Criteria:

1. Presence of another concurrent, actively treated malignancy

    

2. Presence of significant comorbidities that impede ability to engage in exercise, such as congestive heart failure, orthopaedic disorders of the lower limbs or back, neurological disease, or respiratory failure.

    

3. Surgery scheduled in <2 weeks.

Prof. Chia-Chin Lin

School of Nursing

cclin@hku.hk

3917 6633

4.2.2 Supportive Cancer Care

Advanced or Metastatic

Effect of Tai-Chi versus Aerobic Exercise on Emotional Symptom Cluster in Late-stage Lung Cancer Patients: A Mixed-methods Intervention Evaluation with Mediation Analysis.

Key Inclusion Criteria:

1. Diagnosed with stage IIIB or IV non-small cell lung cancer confirmed by pathology, with no other cancer diagnosis within the previous year.

    

2. Experience of sleep disturbance, anxiety, depression, and fatigue in the past week (rating of 1 or more on a 0–10 numeric rating scale [NRS] for each symptom).

    

3. Able to communicate in Cantonese, Mandarin, or English.

    

4. Conscious and alert. Patients who meet the inclusion criteria yet are on sleep/depression/anxiety medications with a fixed dosage regimen in the past 3 months will still be included in the study to increase the generalizability of the findings.

Key Exclusion Criteria:

1. Suffering from a condition that hinders exercise performance (e.g., active neurological disorder, recent heart attack).

    

2. Currently participating in any other exercise or mind-body classes; and/or.

    

3. Performing regular exercises, defined as at least 150 minutes of moderate-intensity exercise weekly.

Prof. Chia-Chin Lin

School of Nursing

cclin@hku.hk

3917 6633