Phase 3 Lung Cancer Trial, Completed NCT04256421 Sponsor: Hoffmann-La Roche Condition: Lung Cancer
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT04256421) enrolled 490 people in total — 247 in the group receiving a placebo plus atezolizumab (Arm A), and 243 in the group receiving tiragolumab plus atezolizumab (Arm B). The trial was measuring several things: how long participants went without their disease getting worse (progression-free survival, or PFS), how long they lived overall (overall survival, or OS), what proportion of participants saw their tumour shrink or disappear (objective response rate, or ORR), and how long those responses lasted (duration of response, or DOR). Notably, the data shows that zero participants in either group were recorded as having "completed" the study, with all participants listed under "not completed" — the reasons for this were not detailed in the reported data. The reported data shows the following numbers for the full group of participants: the median time before disease worsening or death was 5.42 months in Arm A and 5.06 months in Arm B. Median overall survival was reported as 12.91 months in Arm A and 12.75 months in Arm B. When looking at the proportion of people whose tumour shrank or disappeared, the reported figures were approximately 65.6% in Arm A and 70.8% in Arm B across all participants, and 66.7% versus 73.5% in a subgroup analysed separately. For how long those responses lasted, the reported median figures were 5.11 months (Arm A) and 4.17 months (Arm B) across all participants, and 5.59 months versus 4.19 months in the subgroup. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Lung Cancer Trial, Completed

NCT04256421
Completed Phase 3 🇦🇺 Australian site

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:

  • You have been diagnosed with extensive-stage small cell lung cancer (a type of lung cancer that has spread), confirmed through a biopsy or lab test.
  • You have not yet received any treatment for this extensive-stage diagnosis.
  • You are generally able to carry out daily activities with little or no limitation (confirm with trial site, as this is measured using a specific medical scale).
  • You have at least one tumor that can be measured on a scan, according to standard guidelines.
  • Your blood counts and organ function (such as liver and kidneys) are at acceptable levels.
  • If you were previously treated for an earlier, less advanced stage of this cancer, at least 6 months must have passed since your last chemotherapy or radiation treatment.

Who may not be able to join:

  • You have brain or spinal cord spread from your cancer that is causing symptoms or getting worse.
  • You have had a different type of cancer in the last 5 years (with some exceptions for certain low-risk cancers that were fully treated).
  • You have an active autoimmune disease, a history of autoimmune disease, or a condition that weakens your immune system.
  • You have a history of certain types of lung scarring or inflammation, or your scans show signs of active lung inflammation.
  • You have tested positive for HIV.
  • You currently have active hepatitis B or hepatitis C infection.
  • You have a serious infection at the time of joining the trial.
  • You have taken part in another clinical trial and received an experimental treatment within the last 28 days.
  • You have previously been treated with certain types of immunotherapy drugs, including anti-CTLA-4, anti-TIGIT, anti-PD-1, or anti-PD-L1 therapies (confirm with trial site if unsure about your previous treatments).
  • You have received certain immune-boosting treatments within the past 4 weeks or within 5 half-lives of the drug, whichever is longer (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 2 July 2026
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.
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
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
4 February 2020
Est. completion
6 September 2022

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇿 Czechia 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇺 Russia 🇷🇸 Serbia 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS); Overall Survival (OS) in the PAS

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: 2 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