Non-Small Cell Lung Carcinoma (NSCLC) Clinical Trials In Malaysia

Protocol ID

61186372NSC3001

Acronym

PAPILLON

Title

A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Sites

a) Hospital Sultan Ismail (HIS), Johor Bahru

b) Hospital Kuala Lumpur (HKL), Kuala Lumpur

c) Hospital Pulau Pinang (HPP), Pulau Pinang

Inclusion Criteria

a) Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation.

b) Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

c) Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

d) Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.

e) A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.

Exclusion Criteria

a) Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins.

b) Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible).

c) Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.

d) Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.

e) Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid.

Protocol ID

MS200095-0031

Acronym

INSIGHT 2 

Title

A Phase II, two-arm study to investigate tepotinib combined with osimertinib in MET Amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapy (INSIGHT 2 Study).

Sites

a) Hospital Tengku Ampuan Afzan, Kuantan

b) Hospital Umum Sarawak, Kuching

c) Hospital Pulau Pinang, Pulau Pinang

d) Beacon Hospital, Petaling Jaya

e) Pantai Hospital Kuala Lumpur, Kuala Lumpur

Inclusion Criteria

a) Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation.

b) Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria:

i) Radiological documentation of disease progression on first-line osimertinib.

ii) Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (>) 6 months after initiation of osimertinib).

c) Have received only first-line osimertinib as a prior line of therapy in the non-curative advanced or metastatic NSCLC setting.

d) MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening.

e) Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing.

f) Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment.

g) Other protocol defined inclusion criteria could apply.

Exclusion

Criteria

a) Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention.

b) Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia.

c) Inadequate hematological, liver and renal function.

d) Impaired cardiac function.

e) History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment.

f) Hypertension uncontrolled by standard therapies (not stabilized to < 150/90 millimeter of mercury (mmHg).

g) Contraindication to the administration of osimertinib.

h) Other protocol defined exclusion criteria could apply.

Protocol ID

73841937NSC3003

Acronym

MARIPOSA

Title

A Phase 3, Randomized Study of Amivantamab and Lazertinib Combination Therapy Versus Single Agent Osimertinib Versus Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA).

Sites

a) Hospital Sultan Ismail (HIS), Johor Bahru

b) Hospital Kuala Lumpur (HKL), Kuala Lumpur

c) Hospital Tengku Ampuan Afzan (HTAA), Kuantan

Inclusion Criteria

a) Participant must have histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) not amenable to curative therapy.

b) Participant must have a tumor that was previously determined to have exon 19 deletions (Exon 19del) or Exon 21 L858R substitution, as detected by Food and Drug Administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states [US]) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. The biopsy must have been obtained at or after the diagnosis of advanced disease.

c) Unstained tumor tissue (in a quantity sufficient to allow for central analysis of epidermal growth factor receptor (EGFR) mutation status, see Laboratory Manual) and blood (for circulating tumor deoxyribonucleic acid [ctDNA], digital droplet polymerase chain reaction [ddPCR], and pharmacogenomic analysis), both collected at or after the diagnosis of locally advanced or metastatic NSCLC, must be provided.

d) Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level.

e) Participant must have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) v1.1 that has not been previously irradiated. Measurable lesions should not have been biopsied during screening, but if only 1 non-irradiated measurable lesion exists, it may undergo a diagnostic biopsy and be acceptable as a target lesion, provided the baseline tumor assessment scans are performed at least 14 days after the biopsy.

Exclusion Criteria

a) Participant has received any prior systemic treatment for locally advanced or metastatic disease (adjuvant or neoadjuvant therapy is allowed, if administered more than 12 months prior to the development of locally advanced or metastatic disease).

b) Participant has an active or past medical history of leptomeningeal disease.

c) Participant has spinal cord compression that has not been definitively treated with surgery or radiation or requires steroid treatment within 2 weeks prior to randomization.

d) Participant has an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.

e) Participant has known allergy, hypersensitivity, or intolerance to the excipients used in formulation of amivantamab, lazertinib, or osimertinib, or any contraindication to the use of osimertinib.

Protocol ID

NCT03390686

Acronym

SAMSON-II

Title

A Randomized, Double-blind, Parallel Group, Equivalence, Multicenter Phase III Trial to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HD204 to Avastin® in patients with Metastatic or Recurrent Non-squamous Non-small Cell Lung Cancer.

Sites

a) Hospital Raja Perempuan Zainab II, Kota Bharu

Inclusion Criteria

1. Aged ≥ 18 years.

2. ECOG performance status of 0-1

3. Histologically-confirmed metastatic or recurrent non-squamous non-small cell lung cancer

4. At least one measurable lesion according to RECIST v1.1.

5. Able to receive bevacizumab, carboplatin and paclitaxel based on adequate laboratory and clinical parameters

Exclusion

Criteria

1. Diagnosis of small cell carcinoma of the lung or squamous cell carcinoma.

2. Sensitizing EGFR mutations or ALK rearrangements.

3. Increased risk of bleeding determined by investigator based on radiographic / clinical findings.

4. History of systemic chemotherapy administered in the first-line setting for metastatic or recurrent disease of NSCLC.

Protocol ID

INCMGA0012-304

Acronym

POD1UM-304

Title

A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304).

Sites

a) Hospital Tengku Ampuan Afzan, Kuantan

b) Hospital Umum Sarawak, Kuching

Inclusion Criteria

1. Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).

2. No prior systemic treatment for the advanced/metastatic NSCLC.

3. Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy.

4. Measurable disease per RECIST v1.1.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

6. Life expectancy of at least 3 months.

7. Willingness to avoid pregnancy or fathering children.

8. Adequate organ function as indicated by protocol-specified laboratory values.

Exclusion

Criteria

1.Clinically significant cardiac disease within 6 months of start of study treatment.

2. Any major surgery within 3 weeks of the first dose of study treatment.

3. Thoracic radiation therapy of > 30 Gy within 6 months of the first dose of study treatment.

4. History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.

5. Untreated central nervous system metastases and/or carcinomatous meningitis.

6. Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.

7. Active infection requiring systemic therapy or active tuberculosis.

8. Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.

9. Has contraindications to chemotherapy agents used in the study.

10. Has an active autoimmune disease that has required systemic treatment in past 2 years.

11. Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment.

12. Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug).

Protocol ID

61186372PANSC2002

Acronym

Title

A Phase 1/2 Study Evaluating the Safety and Efficacy of Amivantamab and Cetrelimab Combination Therapy in Metastatic Non-small Cell Lung Cancer.

Sites

a) Hospital Umum Sarawak (HUS), Sarawak

b) University Malaya Medical Centre (UMMC), Kuala Lumpur

Inclusion Criteria

1.Participant must have histologically or cytologically confirmed non small cell lung cancer (NSCLC) (any histology), and must have metastatic NSCLC at the time of enrollment: Phase 1 (Combination Dose Selection) Cohort; Metastatic NSCLC progressed on or after standard of care systemic anti-cancer therapy and participant is declining other systemic treatment options, if any;1. Participants without known mutations must have had disease progression on, or have intolerance to, prior platinum-based chemotherapy and PD-(L)1-targeted immunotherapy given concurrently or sequentially, OR 2. Participants with NSCLC characterized by known driver mutations must have had disease progression on, or have intolerance to, appropriate targeted therapies as per local standard of care. Participants may have received prior therapy with amivantamab as long as discontinuation was not due to toxicity. Participants with EGFR mutation must not have had an anti-PD-1/PD-L1 therapy, Phase 2 Expansion Cohorts; Cohort A: Participant’s tumor must have an EGFR exon19del or L858R mutation, as determined by local molecular testing, Cohort B: Participants must have tumors lacking known primary driver mutations and must have PD-L1 expression of greater than or equal to (>=)50 percentage (%), per local testing, and are treatment-naïve in the metastatic setting

2.Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, that has not been previously irradiated

3.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion

Criteria

1. Participant has an uncontrolled illness, including but not limited to:
a. Uncontrolled diabetes, 
b. Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection),
c. Active bleeding diathesis,
d. Impaired oxygenation requiring continuous oxygen supplementation,
e. Psychiatric illness or any other circumstances (including social circumstances) that would limit compliance with study requirements

2. Medical history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening

3. Has an active autoimmune disease or a documented history of autoimmune disease that requires systemic steroids or immunosuppressive agents

4. Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment

5. Participant has a. (or has a history of) leptomeningeal disease (carcinomatous meningitis), b. spinal cord compression not definitively treated with surgery or radiation