Back to resultsA 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 (CATHAYA)
Primary Purpose
Carcinoma, Non-Small Cell Lung
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Atezolizumab
Placebo
Carboplatin
Cisplatin
Pemetrexed
Gemcitabine
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small Cell Lung
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
Arm B: Placebo + platinum-doublet followed by placebo maintenance
Arm Description
Outcomes
Primary Outcome Measures
ctDNA Clearance Rate at 6 Months
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.
Disease-Free Survival (DFS)
Disease-free survival (DFS), as assessed by the investigator, and defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First documented local or distant recurrence of non-small cell lung cancer (NSCLC) after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status; Occurrence of new primary NSCLC (non-small cell lung cancer); Death from any cause in the post-operative ctDNA+ participants
Secondary Outcome Measures
ctDNA Clearance Rate at 12 Months
ctDNA clearance rate in post-operative ctDNA+ participants.
Overall ctDNA Clearance Rate
Overall ctDNA clearance rate in post-operative ctDNA+ participants.
Duration of ctDNA Clearance
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.
Overall survival (OS)
Overall survival (OS) after randomization, defined as the time from randomization to death from any cause in the post-operative ctDNA+ participants.
DFS Rate
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.
Overall ctDNA Clearance Rate in the PD-L1 TC>=1% Population
Overall ctDNA clearance rate in the PD-L1 TC>=1% (Ventana SP263) population in the post-operative ctDNA+ participants.
OS Rate
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.
Time to Confirmed Deterioration (TTCD) in Patient-Reported Functioning and Global Health (GHS)/Quality of Life (QoL)
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.
Percentage of Pariticipants with Adverse Events
Percentage of participants with adverse events in the post-operative ctDNA+ participants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04611776
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
Acronym
CATHAYA
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The positive results from IMpower010 demonstrated benefit by adding atezolizumab as adjuvant therapy in early stage NSCLC. These results raised ethical concerns of enrolling pts to best supportive care over checkpoint inhibition in this setting.
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
March 6, 2025 (Anticipated)
Study Completion Date
January 8, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
Arm Type
Experimental
Arm Title
Arm B: Placebo + platinum-doublet followed by placebo maintenance
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab will be administered intravenously during the induction phase and the maintenance phase.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered intravenously during the induction phase and the maintenance phase.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered intravenously during the induction phase.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin will be administered intravenously during the induction phase.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Pemetrexed will be administered intravenously during the induction phase.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine will be administered intravenously during the induction phase.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered intravenously during the induction phase.
Primary Outcome Measure Information:
Title
ctDNA Clearance Rate at 6 Months
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.
Time Frame
Randomization up to 6 months
Title
Disease-Free Survival (DFS)
Description
Disease-free survival (DFS), as assessed by the investigator, and defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First documented local or distant recurrence of non-small cell lung cancer (NSCLC) after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status; Occurrence of new primary NSCLC (non-small cell lung cancer); Death from any cause in the post-operative ctDNA+ participants
Time Frame
Randomization up to approximatly 159 months
Secondary Outcome Measure Information:
Title
ctDNA Clearance Rate at 12 Months
Description
ctDNA clearance rate in post-operative ctDNA+ participants.
Time Frame
Randomization up to 12 months
Title
Overall ctDNA Clearance Rate
Description
Overall ctDNA clearance rate in post-operative ctDNA+ participants.
Time Frame
Randomization up to approximately 159 months
Title
Duration of ctDNA Clearance
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.
Time Frame
Up to approximatly 159 months
Title
Overall survival (OS)
Description
Overall survival (OS) after randomization, defined as the time from randomization to death from any cause in the post-operative ctDNA+ participants.
Time Frame
Randomization to death from any cause (up to approximately 159 months)
Title
DFS Rate
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.
Time Frame
Randomization to 2 years and 3 years
Title
Overall ctDNA Clearance Rate in the PD-L1 TC>=1% Population
Description
Overall ctDNA clearance rate in the PD-L1 TC>=1% (Ventana SP263) population in the post-operative ctDNA+ participants.
Time Frame
Randomization up to approximately 159 months
Title
OS Rate
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.
Time Frame
Randomization to 2 years and 3 years
Title
Time to Confirmed Deterioration (TTCD) in Patient-Reported Functioning and Global Health (GHS)/Quality of Life (QoL)
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.
Time Frame
Up to approximately 159 months
Title
Percentage of Pariticipants with Adverse Events
Description
Percentage of participants with adverse events in the post-operative ctDNA+ participants.
Time Frame
Randomization up to approximatly 159 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Learn more about this trial
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
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