A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Feb 15, 2025
  • participants needed
    150
  • sponsor
    Hoffmann-La Roche
Updated on 29 May 2022
chemoradiotherapy
cancer chemotherapy
alopecia
atezolizumab
limited stage small cell lung cancer

Summary

This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.

Description

Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.

Details
Condition Carcinoma, Small Cell Lung
Treatment Placebo, Atezolizumab, Tiragolumab
Clinical Study IdentifierNCT04308785
SponsorHoffmann-La Roche
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed Informed Consent Form
ECOG performance status of 0 or 1
Histologically confirmed limited-stage SCLC
Patients who have not progressed during/after chemoradiotherapy
Concurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy
Adequate hematologic and end organ function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later
For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy
Patients must submit a pre-treatment tumor tissue sample

Exclusion Criteria

Histology mixtured or Extensive-stage SCLC (per the Veterans Administration Lung Study Group (VALG) staging system)
Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures
Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease
Malignancies other than SCLC within 5 years prior to study treatment initiation, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab and 90 days after the final dose of tiragolumab, and 6 months for chemotherapy after the final dose of the chemotherapy treatment
Active or history of autoimmune disease or immune deficiency
Uncontrolled or symptomatic hypercalcemia
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Positive test result for HIV
Patients with active hepatitis B or hepatitis C virus
Active tuberculosis
Severe infections within 4 weeks prior to study treatment initiation, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Significant cardiovascular disease
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA4, anti-tigit, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Unresolved toxic effects of grade 2 or higher (CTCAE 5.0), including grade ≥ 2 pneumonitis from previous therapy
Active EBV infection or known or suspected chronic active EBV infection at screening
Clear my responses

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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