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Trial Title:
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
Condition:
Relapsed or Advanced Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Intervention model description:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Almonertinib combined with SHR-1701
Description:
Phase Ⅰb/Phase Ⅱ：
SHR-1701: injection, intravenous infusion
Almonertinib: tablets, oral
Arm group label:
Almonertinib combined with SHR-1701
Intervention type:
Drug
Intervention name:
Almonertinib
Description:
Phase Ⅱ:
Almonertinib: tablets, oral
Arm group label:
Almonertinib
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 1, 2022
Completion date:
July 30, 2027
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05503888
