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Closed (no longer recruiting)Last updated: 3 January 2024

SKYSCRAPER: This phase II study is evaluating how safe and effective combination immunotherapy (atezolizumab + tiragolumab) is alone, or in addition to chemotherapy, as neoadjuvant therapy in people with previously untreated locally advanced non-small cell lung cancerA Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

Clinical summary

Summary

Eligible participants will be assigned to one of two experimental cohorts. Experimental Cohort A will recruit participants with high programmed death-ligand 1 (PD-L1) expressing cancer, and they will receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical removal of the cancer and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator. Experimental Cohort B will recruit participants with any PD-L1 expression level and they will receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles. Atezolizumab (1200mg) will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle. Tiragolumab (600mg) will be administered by IV infusion on Day 1 of each 21-day cycle. Chemotherapy may include: cisplatin/carboplatin + pemetrexed (for non-squamous only), cisplatin/carboplatin + gemcitabine (for squamous only), or carboplatin + paclitaxel.

Conditions

This trial is treating patients with non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

SKYSCRAPER

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

Eligibility

Inclusion

  • Histologically or cytologically confirmed Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology
  • Eligible for R0 resection with curative intent at the time of screening
  • Adequate pulmonary function to be eligible for surgical resection with curative intent
  • Eligible to receive a platinum-based chemotherapy regimen
  • Measurable disease, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Availability of a representative tumor specimen that is suitable for determination of PD-L1 status
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Normal life expectancy, excluding lung cancer mortality risk
  • Adequate hematologic and end-organ function
  • Negative human immunodeficiency virus (HIV) test at screening
  • Negative serology for active hepatitis B virus (HBV) and active hepatitis C virus (HCV) at screening

Exclusion

  • NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC not otherwise specified
  • Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC
  • Any prior therapy for lung cancer
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Active tuberculosis
  • Significant cardiovascular disease
  • NSCLC with an activating EGFR mutation or ALK fusion oncogene
  • Known c-ros oncogene 1 (ROS1) rearrangement
  • History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with negligible risk of metastasis or death
  • Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
  • Prior treatment with CD127 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents
  • Treatment with systemic immunosuppressive medication
  • Pregnancy or breastfeeding

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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

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