Clinical trial · Interventional

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

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

NCT04611776CI-TRIAL-00052302CATHAYAwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): 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.

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Carcinoma, Non-Small Cell Lung	Lung Non-Small Cell Carcinoma	ALIAS	0.90

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
Atezolizumab	Drug	Atezolizumab	ALIAS
Carboplatin	Drug	Carboplatin	ALIAS
Cisplatin	Drug	Cisplatin	ALIAS
Gemcitabine	Drug	Gemcitabine	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
Pemetrexed	Drug	Pemetrexed	ALIAS
Placebo	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
interventionNames
1. Drug: Atezolizumab
2. Drug: Carboplatin
3. Drug: Cisplatin
4. Drug: Pemetrexed
5. Drug: Gemcitabine
6. Drug: Paclitaxel
type
PLACEBO_COMPARATOR
label
Arm B: Placebo + platinum-doublet followed by placebo maintenance
interventionNames
1. Drug: Placebo
2. Drug: Carboplatin
3. Drug: Cisplatin
4. Drug: Pemetrexed
5. Drug: Gemcitabine
6. Drug: Paclitaxel

Primary outcomes (2)

measure
ctDNA Clearance Rate at 6 Months

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.