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RecruitingLast updated: 2 April 2024

SKYSCRAPER-15: This study is assessing the effectiveness and safety of two immunotherapy drugs when given in combination in people with non-small cell lung cancer (NSCLC) who have had prior chemotherapy and a surgeryA Phase III, Randomized, Double-blind Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

Clinical summary

Summary

Eligible participants will be randomly assigned to one of two treatment arms:

In the Experimental Arm, participants will receive atezolizumab and tiragolumab, which will both be administered intravenously (IV).

In the Placebo Comparator Arm, participants will receive atezolizumab and placebo via IV.

Conditions

This trial is treating patients with non-small cell lung cancer who have had prior surgery and chemotherapy

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

SKYSCRAPER-15

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase III, Randomized, Double-blind Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Stage IIB, IIIA, or Select IIIB, PD-L1 Positive, Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Histological or cytological diagnosis of Stage IIB, IIIA, and select IIIB NSCLC of either non-squamous or squamous histology
  • Participants must have had complete resection of NSCLC
  • Participants must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy
  • Participants must have recovered adequately from surgery and from adjuvant chemotherapy
  • Tumor cell PD-L1 expression at >/= 1%
  • Adequate hematologic and end-organ function.

Exclusion

  • Any history of prior NSCLC within the last 5 years
  • Any evidence of residual disease or disease recurrence following surgical resection of NSCLC, or during or following adjuvant chemotherapy
  • NSCLC known to have mutation in the EGFR gene or an ALK fusion oncogene

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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