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

NCT02566993

NCT02566993
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You must be willing and able to give written consent to take part voluntarily
  • You must be 18 years old or older
  • You must have been diagnosed with small-cell lung cancer (SCLC) — confirmed by a lab test on a tissue or cell sample — and have already tried one chemotherapy treatment that included a platinum-based drug, with your cancer getting worse at least 30 days after that treatment ended
  • You may also be eligible if you have a small-cell cancer from an unknown starting point in the body, confirmed by specific lab tests showing a certain level of tumor cell activity (confirm with trial site)
  • You must be well enough to carry out basic daily activities — rated on a standard scale used by doctors (confirm with trial site)
  • Your blood, kidney, liver, and other body functions must be working well enough, checked within about 1–2 weeks before joining the trial
  • It must be at least 3 weeks since your last cancer treatment, and your body must have recovered from any side effects of that treatment
  • If you had radiation to the whole brain, it must be at least 4 weeks ago; if you had preventive brain radiation or radiation to another area, it must be at least 2 weeks ago
  • Women who could become pregnant must agree to use highly effective contraception during the trial and for 6 weeks after treatment ends; men whose partners could become pregnant must use condoms during treatment and for 4 months after the last dose

Who may not be able to join:

  • You have had more than one course of chemotherapy treatment for this cancer
  • You have never received a platinum-based chemotherapy for your small-cell lung cancer
  • You have previously been treated with specific drugs called PM01183, topotecan, or anthracyclines
  • Your cancer is at an early/limited stage and could still be treated with local or targeted treatment to a specific area
  • You may need radiation therapy or surgery within 4 weeks before joining the trial due to bone fractures or pressure on the spinal cord
  • You have cancer that has spread to the brain or nervous system and is causing symptoms, getting worse, or requires steroid medication, within 4 weeks before joining the trial
  • You have certain serious heart conditions, such as chest pain, a recent heart attack, heart failure, or irregular heartbeat
  • You have a weakened immune system, including a known HIV diagnosis
  • You have an ongoing or actively treated long-term liver condition
  • You have an active infection or have needed extra oxygen within 2 weeks before joining the trial
  • You have a lung condition such as widespread scarring or thickening of lung tissue
  • You have a second cancer that has been treated with chemotherapy or radiation
  • You have had a serious fungal infection requiring treatment within 12 weeks before joining the trial
  • You are pregnant or currently breastfeeding

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 3: approximately ~65% 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 3
Sponsor
PharmaMar
Registry
clinicaltrials_gov
Start date
30 August 2016
Est. completion
24 February 2020

Where this trial is recruiting

🇦🇷 Argentina 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇱🇧 Lebanon 🇳🇱 Netherlands 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Overall Survival (OS)

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