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

NCT02674568

NCT02674568
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have been diagnosed with small cell lung cancer (SCLC) that has been confirmed by a tissue test, and your cancer has continued to grow or spread after at least 2 previous treatment regimens, including at least one that contained platinum-based chemotherapy
  • Your tumor tissue has tested positive for a specific protein called DLL3, meaning it appears in at least 1% of your cancer cells, based on a lab test done on a tissue sample
  • You have at least one area of cancer that can be measured on a scan, following standard medical guidelines (RECIST v1.1)
  • You are generally able to carry out daily activities with little or no limitation (confirm with trial site regarding your specific activity level)
  • Your doctor expects you to live for at least 12 weeks
  • If your cancer has spread to the brain, it must have been stable or improving for at least 2 weeks after brain treatment, confirmed by a brain scan taken within 2 weeks before starting the study drug
  • Any serious side effects from previous treatments have mostly cleared up before starting the study drug (with the exception of hair loss)
  • Your blood counts and organ function (such as kidney and liver) are within acceptable ranges based on recent lab tests
  • Enough time has passed since your last cancer treatment before starting this trial — the exact waiting period depends on the type of treatment you received (confirm with trial site for your specific situation)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before your first dose of the study drug

Who may not be able to join:

  • You have a serious uncontrolled medical condition, such as uncontrolled high blood pressure, uncontrolled diabetes, a serious lung condition that required a hospital stay in the last 6 months, or an active seizure disorder within the last 6 months
  • You have had a stroke, mini-stroke (TIA), heart attack, unstable chest pain, or serious heart problems within the past 6 months
  • You have or recently had a serious infection — for example, a severe viral, bacterial, or fungal infection within the last 2 weeks, HIV, or active hepatitis B or C
  • You are currently breastfeeding
  • You are taking high-dose steroid medications (more than 20 mg per day of prednisone or equivalent) within 1 week before starting the study drug
  • You have had another type of cancer within the last 3 years (some exceptions may apply, such as certain skin cancers or early-stage cancers that were fully treated — confirm with trial site)
  • You have previously been treated with a specific type of drug called a PBD-based drug, or you are known to be allergic to the study drug (rovalpituzumab tesirine) or any of its ingredients

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
AbbVie
Registry
clinicaltrials_gov
Start date
25 January 2016
Est. completion
19 October 2018

Primary endpoints

Objective Response Rate; Overall Survival

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