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

NCT05503888 | Not Yet Recruiting Phase 1

• 1 other identifier: SHR-1701-215
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity （Phase Ib）

  21 days after the first dose

• The incidence and severity of ≥ grade 3 treatment-related adverse events (TRAE) and serious adverse events (TRSAE) in the combination of two drugs （Phase Ib）

  from the time when all informed subjects signed the informed consent to the end of the safety follow-up period

• PFS rate at 12 months

  Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first.

  12 months after the first medication for the last subject

Secondary Outcomes (8)

• Adverse Events and Serious Adverse Events

  up to 3 years

• Proportion of dose pauses, dose downgrades and dose terminations due to study-drug related toxicities during the trial

  up to 3 years

• ORR

  up to 3 years

• DCR

  up to 3 years

• DoR

  up to 3 years

Study Arms (2)

Almonertinib combined with SHR-1701

EXPERIMENTAL

Drug: Almonertinib combined with SHR-1701

Almonertinib

PLACEBO COMPARATOR

Drug: Almonertinib

Interventions

Almonertinib combined with SHR-1701 DRUG

Phase Ⅰb/Phase Ⅱ： SHR-1701: injection, intravenous infusion Almonertinib: tablets, oral

Almonertinib combined with SHR-1701

Almonertinib DRUG

Phase Ⅱ: Almonertinib: tablets, oral

Almonertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily joined the study and signed informed consent
• Age 18\~75 years old, both male and female
• Advanced NSCLC diagnosed by histology or cytology, or recurrent NSCLC after radical treatment such as surgery, radiotherapy, chemoradiotherapy
• At least one measurable lesion based on RECIST v1.1 criteria
• ECOG PS score: 0-1
• Have a life expectancy of at least 3 months
• Fertile women must have a negative serum pregnancy test within 3 days before the first dose and must be non-lactating

You may not qualify if:

• Untreated Brain metastases with clinical symptoms; Or accompanied by meningeal metastasis, spinal cord compression，etc.
• Uncontrolled pleural, pericardial, or abdominal effusion with clinical symptoms
• Suffering from other malignant tumors in the past 3 years or at the same time
• Presence of any active or known autoimmune disease
• 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)
• Any severe or uncontrolled ocular lesions that, in the judgment of the investigator, may increase the subject's safety risk
• Have clinical symptoms or diseases of the heart that are not well controlled
• Patients with hypertension who are not well controlled by antihypertensive medication
• 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)
• 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).
• 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
• Have active pulmonary tuberculosis.
• Have known history of human immunodeficiency virus (HIV) seropositive status or acquired immunodeficiency syndrome (AIDS). Have known active hepatitis B or C.
• 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

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

MeSH Terms

Conditions

Recurrence

Interventions

SHR-1701; aumolertinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yanbo Liu

CONTACT

0518-82342973; yanbo.liu@hengrui.com

Weixia Li

CONTACT

0518-82342973; weixia.li@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a multicenter, open-label, dose-exploring, and efficacy expansion phase Ib/II study. The first phase explored two doses of SHR-1701 plus fixed dose of almonertinib to confirm RP2D. The second phase is for efficacy expansion through randomization.

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 17, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: August 17, 2022

Record last verified: 2022-08