Clinical Trials /

A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer

NCT04611776

Description:

This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by placebo in patients with Stage IB to IIIB (T3N2) NSCLC following surgical resection who are positive for ctDNA.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer
  • Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: YO41867
  • NCT ID: NCT04611776

Conditions

  • Carcinoma, Non-Small Cell Lung

Interventions

DrugSynonymsArms
AtezolizumabTecentriqArm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
PlaceboArm B: Placebo + platinum-doublet followed by placebo maintenance
CarboplatinArm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
CisplatinArm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
PemetrexedArm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
GemcitabineArm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
PaclitaxelArm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance

Purpose

This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by placebo in patients with Stage IB to IIIB (T3N2) NSCLC following surgical resection who are positive for ctDNA.

Trial Arms

NameTypeDescriptionInterventions
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenanceExperimental
  • Atezolizumab
  • Carboplatin
  • Cisplatin
  • Pemetrexed
  • Gemcitabine
  • Paclitaxel
Arm B: Placebo + platinum-doublet followed by placebo maintenancePlacebo Comparator
  • Placebo
  • Carboplatin
  • Cisplatin
  • Pemetrexed
  • Gemcitabine
  • Paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Complete resection (R0) and pathologically confirmed Stage IB to select IIIB NSCLC
             (8th edition)

          -  Submission of pre-surgery blood sample and surgically resected tumor tissue slides or
             block

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Normal life expectancy excluding lung cancer mortality risk

          -  Positive ctDNA status in plasma confirmed by central laboratory testing after surgical
             resection and prior to start of adjuvant therapy.

        Exclusion Criteria:

          -  Resected NSCLC with positive margins (R1 or R2)

          -  NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma

          -  Mixed NSCLC and SCLC histology

          -  Any prior therapy for lung cancer, including neoadjuvant therapy, or radiotherapy

          -  NSCLC with an activating EGFR mutation or ALK fusion oncogene

          -  Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including
             anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ctDNA Clearance Rate at 6 Months
Time Frame:Randomization up to 6 months
Safety Issue:
Description:ctDNA clearance rate at 6 months after randomization, defined as the proportion of participants with undetectable ctDNA at 6 months in the post-operative ctDNA+ participants.

Secondary Outcome Measures

Measure:ctDNA Clearance Rate at 12 Months
Time Frame:Randomization up to 12 months
Safety Issue:
Description:ctDNA clearance rate in post-operative ctDNA+ participants.
Measure:Overall ctDNA Clearance Rate
Time Frame:Randomization up to approximately 159 months
Safety Issue:
Description:Overall ctDNA clearance rate in post-operative ctDNA+ participants.
Measure:Duration of ctDNA Clearance
Time Frame:Up to approximatly 159 months
Safety Issue:
Description:Duration of ctDNA clearance, defined as the time from the first documented ctDNA clearance to ctDNA detection, investigator-assessed radiographic or biopsy confirmed disease recurrence, or death from any cause, whichever occurs first in post-operative ctDNA+ participants.
Measure:Overall survival (OS)
Time Frame:Randomization to death from any cause (up to approximately 159 months)
Safety Issue:
Description:Overall survival (OS) after randomization, defined as the time from randomization to death from any cause in the post-operative ctDNA+ participants.
Measure:DFS Rate
Time Frame:Randomization to 2 years and 3 years
Safety Issue:
Description:DFS rate at 2 years and 3 years, defined as the probability that a participant has not experienced disease recurrence, a new primary NSCLC, or death from any cause, as determined by the investigator at 2 years and 3 years, respectively in the post-operative ctDNA+ participants.
Measure:Overall ctDNA Clearance Rate in the PD-L1 TC>=1% Population
Time Frame:Randomization up to approximately 159 months
Safety Issue:
Description:Overall ctDNA clearance rate in the PD-L1 TC>=1% (Ventana SP263) population in the post-operative ctDNA+ participants.
Measure:OS Rate
Time Frame:Randomization to 2 years and 3 years
Safety Issue:
Description:OS rate at 2 years and 3 years, defined as the probability that a patient has not experienced death from any cause at 2 years and 3 years, respectively in the post-operative ctDNA+ participants.
Measure:Time to Confirmed Deterioration (TTCD) in Patient-Reported Functioning and Global Health (GHS)/Quality of Life (QoL)
Time Frame:Up to approximately 159 months
Safety Issue:
Description:Time to confirmed deterioration (TTCD) in patient-reported functioning and global health (GHS)/quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain, as measured through the use of the EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) in the post-operative ctDNA+ participants.
Measure:Percentage of Pariticipants with Adverse Events
Time Frame:Randomization up to approximatly 159 months
Safety Issue:
Description:Percentage of participants with adverse events in the post-operative ctDNA+ participants.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

October 30, 2020