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

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05132413
• Collaborator: (none)
• Enrollment: 561
• Arms: 3
• Anticipated Duration (Months): 36

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer	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	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 561 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: SHR-1701/ Placebo Plus Chemotherapy With or Without BevacizumabSHR-1701/ Placebo Plus Chemotherapy With or Without Bevacizumab
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase 3, Randomized Double-blind, Placebo-controlled, Multicenter Study 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
• Anticipated Study Start Date: Dec 30, 2021
• Anticipated Primary Completion Date: Dec 30, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: treatment group	Drug: SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab; SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
Placebo Comparator: Placebo group 1	Drug: Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin; Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
Placebo Comparator: Placebo group 2	Drug: Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin; Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin

Outcome Measures

Primary Outcome Measures

1. 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]

2. BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II） [2 years]

Secondary Outcome Measures

1. Progression free survival (PFS)（Stage I） [2 years]

2. Objective response rate (ORR)（Stage I） [2 years]

3. Disease control rate (DCR) （Stage I） [2 years]

4. Duration of response (DOR) （Stage I） [2 years]

5. Overall survival (OS) （Stage I） [2 years]

6. Progression free survival (PFS)（Stage II） [2 years]

7. Objective response rate (ORR)（Stage II） [2 years]

8. Disease control rate (DCR)（Stage II） [2 years]

9. Duration of response (DOR) （Stage II） [2 years]

10. Overall survival (OS) （Stage II） [2 years]

11. Incidence and severity of adverse events (AEs), serious adverse events （Stage II） [2 years]

12. (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II） [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05132413
• Other Study ID Numbers: SHR-1701-III-310
• First Posted: Nov 24, 2021
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Bevacizumab; Cisplatin; Carboplatin; Pemetrexed

Study Results

No Results Posted as of Nov 24, 2021