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NCT02609776

NCT02609776
Active, Not Recruiting Phase 1 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed with surgery, confirmed by a lab test on a tissue or cell sample.
  • Your cancer has continued to grow after receiving standard treatments, or you are not able to receive those treatments, or you have chosen not to receive them (which must be recorded in your medical file).
  • Depending on which group (cohort) you may join, your tumor may need to have specific genetic changes — such as mutations in genes called EGFR or MET — confirmed by a certified laboratory; the trial team will explain which apply to you (confirm with trial site).
  • For some groups, your tumor tissue (either stored from before or newly collected) must show certain protein markers called EGFR and/or MET when tested by a special lab method.
  • You are generally able to carry out your daily activities and care for yourself, though you may not be able to do heavy physical work (this is measured on a standard scale called ECOG, where a score of 0 means fully active and 1 means slightly limited).
  • For one specific part of the trial involving chemotherapy: you must be suitable to receive a combination of two chemotherapy drugs (carboplatin and pemetrexed) and be willing to also receive the experimental drug Amivantamab.
  • Your cancer must be measurable or detectable on scans, depending on which part of the trial you are joining.

Who may not be able to join:

  • You have another serious illness that is not well controlled, such as very high blood pressure, poorly managed diabetes, an active infection, or a mental health condition that might make it hard to follow the study schedule.
  • You require continuous oxygen therapy for a medical condition.
  • You have received chemotherapy, targeted therapy, immunotherapy, or another experimental cancer treatment too recently before the start of the trial (generally within 2 to 4 weeks, depending on the treatment).
  • Side effects from your previous cancer treatments have not yet cleared up to a mild or baseline level (with some exceptions, such as hair loss or mild nerve tingling, which may still be present).
  • You have brain metastases (cancer that has spread to the brain) that have not yet been treated — though if your brain metastases have been treated, are stable, and are causing no symptoms for at least 2 weeks, you may still be eligible (confirm with trial site).
  • You have had another type of cancer in the past 3 years, other than certain minor skin cancers or a very early-stage cervical condition, or unless your doctor considers it very unlikely to return.
  • You have not fully recovered from a major operation or serious injury before starting the trial.
  • You have had a major surgical procedure involving entry into a body cavity within the past 4 weeks without fully recovering beforehand.
  • You have had a significant injury within 3 weeks before starting the trial, or have a medical condition that would seriously affect your ability to heal wounds during the trial.
  • You are expected to need major surgery while on the trial or within 6 months after your last dose of the study drug.
  • For certain groups: previous treatment with specific types of targeted therapies or immunotherapy may make you ineligible, depending on which group you are being considered for (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 1
Sponsor
Janssen Research & Development, LLC
Registry
clinicaltrials_gov
Start date
24 May 2016
Est. completion
31 December 2026

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇯🇵 Japan 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1: Number of Participants With Dose Limiting Toxicity (DLT); Part 2: Number of Participants With Adverse Events (AEs) and Serious AEs; Part 2: Overall Response Rate (ORR); Part 2: Duration of Response (DOR); Part 2: Percentage of Participants With Clinical Benefit; Trough Serum Concentration (Ctrough) of Amivantamab; Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Amivantamab

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov