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Closed (no longer recruiting)Last updated: 5 February 2024

PAPILLON: This trial aims to understand whether it is better to use a form of targeted therapy in combination with chemotherapy in the treatment of locally advanced or metastatic non-small cell lung cancer, compared to using chemotherapy aloneA 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

Clinical summary


Eligible participants will be randomised to receive Pemetrexed and Carboplatin (chemotherapy) alone or in addition to Amivantamab. In Arm A and B, participants will receive 500 milligram per meter square (mg/m^2) intravenous (IV) pemetrexed on Day 1 of each 21-day cycle, in combination with carboplatin for up to 4 cycles, and then as maintenance monotherapy until disease progression. In addition to receiving chemotherapy treatment, participants in Arm A will also receive 1400mg IV amivantamab once weekly up to Cycle 2 Day 1, then 1750 mg IV amivantamab on Day 1 of each 21-day cycle, starting with Cycle 3. Participants in Arm B will receive chemotherapy alone.


This trial is treating patients with non-small cell lung cancer.


Lung Cancers Lung cancer





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Trial sponsor

Janssen-Cilag Pty Ltd

Scientific 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



  • 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
  • Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • 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
  • 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


  • Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
  • 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)
  • Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
  • 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


  • Your cancer has spread to other parts of the body.


  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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