A Study of SHR-1701 Plus Bevacizumab and Chemotherapy in Non-Small-Cell-Lung-Cancer

Phase 3

Not yet recruiting

• Conditions: Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer
• Interventions: Drug: SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab; Drug: Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin; Drug: Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin

• Registration Number: NCT05132413
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Brief Summary

Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-12
• Study First Submitted QC: 2021-11-12
• Last Update Submitted: 2021-11-12
• Study First Posted: 2021-11-24
• Last Update Posted: 2021-11-24
• Study Start: 2021-12-30
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 561

Inclusion Criteria

A subject must satisfy all of the following criteria to be considered for inclusion in the study:

1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer.
2. Failed with prior EGFR-TKIs treatments.
3. Measurable disease, as defined by RECIST v1.1
4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1
5. Life expectancy ≥ 3 months
6. Adequate hematologic and end-organ function as defined in the protocol

Exclusion Criteria

A subject who meets any of the following criteria will be excluded from study entry:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC.
2. Symptomatic, untreated or active central nervous system metastases.
3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment
4. With any active autoimmune disease or history of autoimmune disease.
5. Inadequately controlled hypertension.
6. Tumour infiltration into the great vessels on imaging.
7. History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment.
8. Uncontrolled tumour-related pain.
9. Patients with active hepatitis B or hepatitis C
10. Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab	-
Placebo group 1	Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin	-
Placebo group 2	Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I）	2 years
BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II）	2 years

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)（Stage II）	2 years
Progression free survival (PFS)（Stage I）	2 years
Objective response rate (ORR)（Stage I）	2 years
Disease control rate (DCR) （Stage I）	2 years
Duration of response (DOR) （Stage I）	2 years
Overall survival (OS) （Stage I）	2 years
Objective response rate (ORR)（Stage II）	2 years
(SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II）	2 years
Disease control rate (DCR)（Stage II）	2 years
Duration of response (DOR) （Stage II）	2 years
Overall survival (OS) （Stage II）	2 years
Incidence and severity of adverse events (AEs), serious adverse events （Stage II）	2 years