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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 561
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yuanchao Wang; Phone Number: 0518-81220278; Email: yuanchao.wang@hengrui.com
• Study Contact Backup: Name: You Li; Phone Number: 0518-81220278; Email: you.li.yl1@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Progression free survival (PFS)（Stage II）	2 years
Objective response rate (ORR)（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
(SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II）	2 years

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 30, 2021
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: November 12, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Folic Acid Antagonists; Carboplatin; Cisplatin; Bevacizumab; Pemetrexed
• Other Study ID Numbers: SHR-1701-III-310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No