Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC

Phase 3

Completed

• Conditions: Lung Neoplasms
• Interventions: Drug: Sintilimab; Drug: Pemetrexed; Drug: Platinum; Drug: Placebos

• Registration Number: NCT03607539
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

Efficacy and Safety Evaluation of IBI308 in Patients with advanced or metastatic Non-squamous NSCLC

Detailed Description

Sintilimab is expected to increase the PFS from 6 months to 9.2 months. Anti-PD-1 therapy in Chinese non-squamous NSCLC naïve patients will be investigated in this clinical trial.

Additionally the correlation between PD-L1 expression and the response to Sintilimab treatment in Chinese non-squamous NSCLC as well as the role of iRECIST in immune checkpoint inhibitor treatment evaluation will also be assessed.

Study Timeline

• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-07-31
• Study Start: 2018-08-23
• Results First Submitted: 2020-11-30
• Results First Submitted QC: 2021-01-27
• Results First Posted: 2021-02-16
• Status Verified: 2023-02
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sintilimab in combination with pemetrexed and platinum	Sintilimab	Injection; dosage form: 10ml: 100mg; frequency: 200mgQ3W (qualer 3 weeks); duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria Sintilimab 200mg + pemetrexed/ platinum 4 cycles then Sintilimab 200mg + pemetrexed maintains
Sintilimab in combination with pemetrexed and platinum	Pemetrexed	Injection; dosage form: 10ml: 100mg; frequency: 200mgQ3W (qualer 3 weeks); duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria Sintilimab 200mg + pemetrexed/ platinum 4 cycles then Sintilimab 200mg + pemetrexed maintains
Sintilimab in combination with pemetrexed and platinum	Platinum	Injection; dosage form: 10ml: 100mg; frequency: 200mgQ3W (qualer 3 weeks); duration: randomization to the date of the first documented tumor progression per RECIST v1.1 criteria Sintilimab 200mg + pemetrexed/ platinum 4 cycles then Sintilimab 200mg + pemetrexed maintains
Sitilimab Placebo Comparator	Placebos	placebo 2 vials + pemetrexed/ platinum 4 cycles then Sintilimab 200mg + pemetrexed maintains
Sitilimab Placebo Comparator	Pemetrexed	placebo 2 vials + pemetrexed/ platinum 4 cycles then Sintilimab 200mg + pemetrexed maintains
Sitilimab Placebo Comparator	Platinum	placebo 2 vials + pemetrexed/ platinum 4 cycles then Sintilimab 200mg + pemetrexed maintains

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Independent Radiographic Review Committee (IRRC)	Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)	PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)	The analysis population consisted of all randomized participants.
Objective Response Rate (ORR) by IRRC Assessment	Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)	ORR was defined as the percentage of participants in the analysis population who had a confirmed CR (disappearance of all lesions) or PR (at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a confirmed CR or PR according to RECIST 1.1 as assessed by IRC was reported as the ORR
Disease Control Rate (DCR) by IRRC Assessment	Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)
Time to Response (TTR) by IRRC Assessment	Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)	TTR was defined as the time of participants from the first treatment administration to the first incidence of a confirmed CR (disappearance of all lesions) or PR (at least a 30% decrease in the sum of diameters \[SOD\] of target lesions, taking as reference the baseline SOD) according to RECIST 1.1, which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The time from first treatment administration to the first incidence of treatment response was reported as the TTR
Duration of Response (DOR) by IRRC Assessment	From time of first documented evidence of CR or PR trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, China