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Double immunotherapy attack shows promise in tough lung cancer

NCT ID NCT04665856

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This Phase 3 study tests whether adding tiragolumab (an experimental immunotherapy) to the standard combination of atezolizumab plus chemotherapy can help people with untreated, widespread small cell lung cancer live longer without their disease worsening. About 123 participants in China received either the triple therapy or a placebo version. The main goals are to see if the new combo delays cancer growth and improves overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tiragolumab (an immunotherapy drug) combined with atezolizumab (Tecentriq) and chemotherapy (carboplatin and etoposide)
What this could lead to
If successful, this combination could become a new standard first-line treatment for extensive-stage small cell lung cancer, potentially improving how long patients live without their cancer growing.
What could go wrong
This is a Phase 3 trial, but it only enrolled 123 people in China, so results may not apply to everyone. Adding another immunotherapy (tiragolumab) may increase side effects without guaranteeing better outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

123 people

The number who actually took part.

Started

Dec 2020

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the modified Veterans Administration Lung Study Group (VALG) staging system * No prior systemic treatment for ES-SCLC * For participants who have received prior chemoradiotherapy for limited-stage SCLC must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC * Measurable diseases as defined by RECIST v1.1 * Submission of a pre-treatment tumor tissue sample * Adequate hematologic and end-organ function * Participants not receiving therapeutic anticoagulation with International Normalized Ratio (INR) and Activated Clotting Time (aPTT) \</= 1.5 x ULN * Participants receiving therapeutic anticoagulation: stable anticoagulant regimen * Negative Human Immunodeficiency Virus (HIV) test at screening * Negative hepatitis B surface antigen (HBsAg) test at screening * Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) and/or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test * Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test * Negative Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM test or negative EBV polymerase chain reaction (PCR) test at screening * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm. Exclusion Criteria: * Symptomatic or actively progressing central nervous system (CNS) metastases * Spinal cord compression * Leptomeningeal disease * Uncontrolled pleural effusion, pericardial effusion, or ascites * Uncontrolled or symptomatic hypercalcemia * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse * Malignancies other than SCLC within 5 years prior to randomization * Active or history of autoimmune disease or immune deficiencies * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computer Tomography (CT) scan * Known active tuberculosis, Current treatment with anti-viral therapy for HBV or HCV * Severe chronic or active infection * Treatment with therapeutic oral or IV antibiotics * Significant cardiovascular disease * Major surgical procedure other than for diagnosis * Prior allogeneic bone marrow transplantation or solid organ transplant * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition * Administration of a live, attenuated vaccine * Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies * Treatment with systemic immunostimulatory agents * Treatment with systemic immunosuppressive medications * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese Hamster Ovary (CHO) cell products or to any component of the tiragolumab or atezolizumab formulations * History of allergic reactions to carboplatin or etoposide * Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or within 90 days after the final dose of tiragolumab or for 6 months after the final dose of carboplatin or etoposide.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • Beijing Chest Hospital

    Beijing, 101149, China

  • Cancer Center of Guangzhou Medical University

    Guangzhou, 510000, China

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Fujian Provincial Cancer Hospital

    Fuzhou, 350014, China

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Henan Cancer Hospital

    Zhengzhou, 450008, China

  • Shanghai Chest Hospital

    Shanghai, 200000, China

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310016, China

  • The 1st Affiliated Hospital of Nanchang Unversity

    Nanchang, 330006, China

  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

  • the First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233000, China

  • the First Hospital of Jilin University

    Changchun, 130021, China

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