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

NCT ID: NCT05132413

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-30

Study Completion Date

2024-12-30

Brief Summary

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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

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Conditions

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Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR-1701/ Placebo Plus Chemotherapy With or Without Bevacizumab
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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treatment group

Group Type EXPERIMENTAL

SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab

Intervention Type DRUG

SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab

Placebo group 1

Group Type PLACEBO_COMPARATOR

Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin

Intervention Type DRUG

Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin

Placebo group 2

Group Type PLACEBO_COMPARATOR

Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin

Intervention Type DRUG

Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin

Interventions

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SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab

SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab

Intervention Type DRUG

Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin

Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin

Intervention Type DRUG

Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin

Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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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

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Yuanchao Wang

Role: CONTACT

Phone: 0518-81220278

Email: [email protected]

You Li

Role: CONTACT

Phone: 0518-81220278

Email: [email protected]

Other Identifiers

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SHR-1701-III-310

Identifier Type: -

Identifier Source: org_study_id