Phase Ib/II Study of Almonertinib Combined With SHR-1701 in the Treatment of Relapsed or Advanced Non-small Cell Lung Cancer

NCT ID: NCT05503888

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2027-07-30

Brief Summary

To evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of Almonertinib combined with SHR-1701 in relapsed or advanced NSCLC To evaluate the efficacy of Almonertinib combined with SHR-1701 in the first-line treatment of relapsed or advanced NSCLC

Conditions

Relapsed or Advanced Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Almonertinib combined with SHR-1701

Group Type: EXPERIMENTAL

Almonertinib combined with SHR-1701

Intervention Type: DRUG

Phase Ⅰb/Phase Ⅱ：

SHR-1701: injection, intravenous infusion

Almonertinib: tablets, oral

Almonertinib

Group Type: PLACEBO_COMPARATOR

Almonertinib

Intervention Type: DRUG

Phase Ⅱ:

Almonertinib: tablets, oral

Interventions

Almonertinib combined with SHR-1701

Phase Ⅰb/Phase Ⅱ：

SHR-1701: injection, intravenous infusion

Almonertinib: tablets, oral

Intervention Type: DRUG

Almonertinib

Phase Ⅱ:

Almonertinib: tablets, oral

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients voluntarily joined the study and signed informed consent

2. Age 18~75 years old, both male and female

3. Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy

4. At least one measurable lesion based on RECIST v1.1 criteria

5. ECOG PS score: 0-1

6. Have a life expectancy of at least 3 months

7. Fertile women must have a negative serum pregnancy test within 3 days before the first dose and must be non-lactating

Exclusion Criteria

1. Untreated Brain metastases with clinical symptoms; Or accompanied by meningeal metastasis, spinal cord compression，etc.

2. Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms

3. Suffering from other malignant tumors in the past 3 years or at the same time

4. Presence of any active or known autoimmune disease

5. Subjects who had been systematically treated with corticosteroids (>10 mg/ day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose (randomization)

6. Any severe or uncontrolled ocular lesions that, in the judgment of the investigator, may increase the subject's safety risk

7. Have clinical symptoms or diseases of the heart that are not well controlled

8. Patients with hypertension who are not well controlled by antihypertensive medication

9. Any bleeding event of grade 2 or more or hemoptysis (volume of hemoptysis ≥2ml in a single episode) occurring within 2 weeks before the first dose (randomization); Clinically significant bleeding symptoms or definite bleeding tendency before the first medication (randomization)

10. Have known history of serious infections within 1 month prior to the first dose(randomization), including but not limited to infectious complications that require hospitalization, bacteremia, and severe pneumonia; use antibiotics within 1 week prior to the first dose(randomization); have any active infections requiring intravenous systemic therapy, or have a fever > 38.5°C of unknown cause before the first dose(randomization).

11. Have active or prior documented interstitial pneumonia/interstitial lung disease or pneumonitis that requires glucocorticoid treatment (e.g., radiation pneumonitis); Have active pneumonia at present

12. Have active pulmonary tuberculosis.

13. Have known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). Have known active hepatitis B or C.

14. Had received lung radiation therapy within 6 months before the first dose (randomization); Had received major surgical treatment (except diagnostic surgery), systemic chemotherapy, immunotherapy, or other investigational drugs within 4 weeks prior to the first medication (randomization); Received palliative radiotherapy within 2 weeks before the first dose (randomization); Oral administration of molecular targeted drugs, less than 5 half-lives before discontinuation of the drug to the first dose (randomization); Failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE grade≤1

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yanbo Liu

Role: CONTACT

yanbo.liu@hengrui.com

0518-82342973

Weixia Li

Role: CONTACT

weixia.li@hengrui.com

0518-82342973

Other Identifiers

SHR-1701-215

Identifier Type: -

Identifier Source: org_study_id