Back to Lung Cancer
This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT02039674

NCT02039674
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with advanced non-small cell lung cancer (stage 3B or stage 4).
  • Your cancer came back more than 1 year after finishing treatment for an earlier stage of lung cancer (stages 1–3A), and you have not received any other treatment for the cancer since it came back.
  • Any side effects from your most recent cancer treatment have cleared up (hair loss is the exception — that does not need to have resolved).
  • You have at least one tumor or area of cancer that can be measured on a scan.
  • You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site what this means for your situation).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 72 hours (about 3 days) before starting the study.
  • If you could father or become pregnant, you must agree to use reliable birth control throughout the study and for a set period after your last dose of study treatment.

Who may not be able to join:

  • You have taken part in another clinical trial or used an experimental medical device within the last 4 weeks.
  • You are expected to need any other cancer treatment while taking part in this study.
  • You are currently taking long-term steroid medication or any other medication that suppresses your immune system.
  • You have received a live-virus vaccine (such as certain flu or travel vaccines) within the last 30 days.
  • You have active diverticulitis, an abscess in your abdomen, a bowel blockage, or cancer that has spread widely inside the abdomen (confirm with trial site).
  • You have a history of a blood cancer, a brain tumor, a type of cancer called sarcoma, or any other type of cancer — unless you received treatment that may have cured it and there has been no sign of it for at least 5 years.
  • Your lung cancer has actively spread to the brain or the lining around the brain and spine.
  • You have had a severe allergic reaction to a similar type of medication (a monoclonal antibody) in the past.
  • You have an autoimmune disease (where your immune system attacks your own body) that has needed treatment with medication in the last 2 years (hormone replacement for deficiencies is allowed).
  • You have previously received a specific type of immunotherapy drug that targets certain immune pathways (known as anti-PD-1, PD-L1, PD-L2, or similar agents).
  • You have had chemotherapy, biological cancer therapy, or major surgery within the last 3 weeks.
  • You have had radiation therapy to the lung above a certain dose level within the last 6 months (confirm with trial site).
  • You have received a certain type of targeted cancer pill (tyrosine kinase inhibitor) or palliative radiation within the last 7 days.
  • You currently have an infection that requires treatment.
  • You have a history of HIV.
  • You currently have active Hepatitis B or Hepatitis C.
  • You have a significant build-up of fluid in your abdomen or around your lungs that is causing symptoms.
  • You have a lung condition involving inflammation or scarring of the lung tissue that requires steroid medication taken by mouth or through a drip.
  • You are pregnant, breastfeeding, or planning to have a child during the study period.
  • You have a psychiatric condition or a problem with drug or alcohol misuse.

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 2: approximately ~30% 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
Completed
Phase
Phase 2
Sponsor
Merck Sharp & Dohme LLC
Registry
clinicaltrials_gov
Start date
21 February 2014
Est. completion
7 November 2016

Primary endpoints

Part 2 Cohorts G+ and G-: Objective Response Rate (ORR); Part 2 Cohorts D4 and H: Objective Response Rate (ORR); All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)

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