CATHAYA: 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
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
|
Drug: Atezolizumab
Atezolizumab will be administered intravenously during the induction phase and the maintenance phase.
Other Names:
Drug: Carboplatin
Carboplatin will be administered intravenously during the induction phase.
Drug: Cisplatin
Cisplatin will be administered intravenously during the induction phase.
Drug: Pemetrexed
Pemetrexed will be administered intravenously during the induction phase.
Drug: Gemcitabine
Gemcitabine will be administered intravenously during the induction phase.
Drug: Paclitaxel
Paclitaxel will be administered intravenously during the induction phase.
|
| Placebo Comparator: Arm B: Placebo + platinum-doublet followed by placebo maintenance
|
Drug: Placebo
Placebo will be administered intravenously during the induction phase and the maintenance phase.
Drug: Carboplatin
Carboplatin will be administered intravenously during the induction phase.
Drug: Cisplatin
Cisplatin will be administered intravenously during the induction phase.
Drug: Pemetrexed
Pemetrexed will be administered intravenously during the induction phase.
Drug: Gemcitabine
Gemcitabine will be administered intravenously during the induction phase.
Drug: Paclitaxel
Paclitaxel will be administered intravenously during the induction phase.
|
Outcome Measures
Primary Outcome Measures
- ctDNA Clearance Rate at 6 Months [Randomization up to 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) [Randomization up to approximatly 159 months]
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 [Randomization up to 12 months]
ctDNA clearance rate in post-operative ctDNA+ participants.
- Overall ctDNA Clearance Rate [Randomization up to approximately 159 months]
Overall ctDNA clearance rate in post-operative ctDNA+ participants.
- Duration of ctDNA Clearance [Up to approximatly 159 months]
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) [Randomization to death from any cause (up to approximately 159 months)]
Overall survival (OS) after randomization, defined as the time from randomization to death from any cause in the post-operative ctDNA+ participants.
- DFS Rate [Randomization to 2 years and 3 years]
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 [Randomization up to approximately 159 months]
Overall ctDNA clearance rate in the PD-L1 TC>=1% (Ventana SP263) population in the post-operative ctDNA+ participants.
- OS Rate [Randomization to 2 years and 3 years]
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) [Up to approximately 159 months]
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 [Randomization up to approximatly 159 months]
Percentage of participants with adverse events in the post-operative ctDNA+ participants.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Complete resection (R0) and pathologically confirmed Stage IB to select IIIB NSCLC (8th edition)
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Submission of pre-surgery blood sample and surgically resected tumor tissue slides or block
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Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
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Normal life expectancy excluding lung cancer mortality risk
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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)
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NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
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Mixed NSCLC and SCLC histology
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Any prior therapy for lung cancer, including neoadjuvant therapy, or radiotherapy
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NSCLC with an activating EGFR mutation or ALK fusion oncogene
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Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YO41867