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.
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
Drug | Synonyms | Arms |
---|
Atezolizumab | Tecentriq | Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance |
Placebo | | Arm B: Placebo + platinum-doublet followed by placebo maintenance |
Carboplatin | | Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance |
Cisplatin | | Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance |
Pemetrexed | | Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance |
Gemcitabine | | Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance |
Paclitaxel | | Arm 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
Name | Type | Description | Interventions |
---|
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance | Experimental | | - Atezolizumab
- Carboplatin
- Cisplatin
- Pemetrexed
- Gemcitabine
- Paclitaxel
|
Arm B: Placebo + platinum-doublet followed by placebo maintenance | Placebo 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: | Withdrawn |
Lead Sponsor: | Hoffmann-La Roche |
Last Updated
June 16, 2021