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.

 

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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.

 

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