Phase 2 Lung Cancer Trial, Recruiting NCT04696575 Sponsor: Roswell Park Cancer Institute Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT04696575
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older.
  • People whose general health and ability to carry out daily activities meets a specific standard (rated 0 or 1 on a scale used by doctors, meaning fully active or able to do light work).
  • People with a confirmed diagnosis of small cell lung cancer (SCLC), proven through a tissue or cell sample.
  • People whose cancer has spread widely — for example, to the fluid around the lungs, to other parts of the same lung or the other lung, or to areas outside the chest.
  • People whose cancer can be measured on scans before starting platinum-based chemotherapy (a common type of chemotherapy).
  • People whose blood test results meet specific levels for white blood cells, platelets, red blood cells, kidney function, and liver function (the trial site will check these).
  • Newly diagnosed patients who have received no more than one cycle of standard chemotherapy or combined chemotherapy and immunotherapy before joining the trial.
  • People whose cancer has come back after earlier treatment, if they received no more than one course of platinum-based chemotherapy previously, and their last platinum-based treatment was given at least 12 months before the cancer returned — and their cancer did not get worse while they were on that earlier treatment.
  • People who are able to become pregnant must agree to use effective contraception during the study, and must tell their treating doctor immediately if pregnancy occurs or is suspected.
  • People who understand the experimental nature of the study and sign a written consent form before any study procedures begin.

Who may not be able to join:

  • People who received anti-cancer chemotherapy or combined chemotherapy and immunotherapy within the 4 weeks before starting the study drug (beyond what is specifically allowed in the inclusion rules above).
  • People with brain metastases (cancer that has spread to the brain) that are causing symptoms — though people whose brain metastases have been treated and whose symptoms have improved or been controlled for at least two weeks may still be considered eligible; people with no symptoms from brain metastases who are being treated with chemotherapy alone may also be considered eligible if there are no more than 6 lesions, each smaller than 1 cm (confirm with trial site).
  • People whose cancer has spread to the membranes lining the brain and spinal cord (leptomeningeal involvement), regardless of whether it has been treated.
  • People who have taken part in another interventional clinical trial within the 28 days before enrolling.
  • People who had major surgery within 14 days before starting the study drug, or who have not yet recovered from major side effects of a previous surgery (a tumour biopsy does not count as major surgery).
  • People who test positive for HIV, active hepatitis B, or active/untreated hepatitis C — mandatory testing is required before enrolment. People with past or resolved hepatitis B, or hepatitis C where a specific follow-up test (PCR) shows no active virus, may still be considered eligible (confirm with trial site).
  • People with serious active infections or other serious uncontrolled medical conditions, including active chronic viral hepatitis.
  • People with a known allergic reaction to the study drugs or similar medicines.
  • People with certain serious heart conditions, including a heart attack or blood clot in an artery or vein within the past 6 months, severe or unstable chest pain, heart failure classified as severe (Class III or IV), or poorly controlled irregular heartbeat.
  • People with active autoimmune diseases, or a history of autoimmune disease that required immune-suppressing treatment within the past two years, will not be able to receive one of the study drugs (atezolizumab) — though the trial site may still consider them eligible for the other drugs in the treatment (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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
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.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Roswell Park Cancer Institute
Registry
ClinicalTrials.gov
Start date
2 July 2021
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Progression-free 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: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov