A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

STATUS

Recruiting
End date

Mar 15, 2024
participants needed

636
sponsor

Shanghai Henlius Biotech

Send

Updated on 13 May 2022

See if I qualify

cancer

measurable disease

avastin

lung cancer

pemetrexed

carboplatin

ROS1

EGFR

administration intravenous

Summary

This study involves a two-part design. Part 1 is designed to evaluate the safety and tolerability of the 4 drug (HLX10+HLX04+carboplatin+pemetrexed). Part 2 is a randomized, open-label study, which will evaluate the safety and efficacy of HLX10 in combination with carboplatin+pemetrexed with or without HLX04(biosimilar of avastin) compared with treatment with carboplatin+pemetrexed in 1st line Stage IIIB/IIIC or IV non-squamous NSCLC. Participants will be randomized in a 1:1:1 ratio to Arm A (HLX10+HLX04+Carboplatin+Pemetrexed), Arm B (HLX10+HLX04 placebo+Carboplatin+Pemetrexed), or Arm C (HLX10 placebo + HLX04 placebo+Carboplatin+Pemetrexed).

Details

Condition	Carcinoma, Non-Small-Cell Lung
Treatment	carboplatin, Pemetrexed, HLX10, an engineered anti-PD-1 antibody, HLX04, a bevacizumab biosimilar
Clinical Study Identifier	NCT03952403
Sponsor	Shanghai Henlius Biotech
Last Modified on	13 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically or cytologically confirmed, Stage IIIB/IIIC or IV non-squamous NSCLC
	Participants with no EGFR, ALK and ROS1 mutation
	Participants with no prior treatment for Stage IIIB/IIIC or IV non-squamous NSCLC
	Measurable disease as defined by RECIST v1.1
	Eastern Cooperative Oncology Group performance status 0 or 1
	Adequate hematologic and end organ function
Exclusion Criteria
	Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
	Active central nervous system metastases
	Prior treatment with cluster of differentiation immune checkpoint blockade therapies or Bevacizumab
	Has received a surgical operation within 4 weeks from the initial drug administration
	Active or suspected autoimmune diseases. Subjects in a stable state with no need for systemic immunosuppressant therapy are allowed to enroll
	Currently having or have had interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis and severe impaired pulmonary function that may interfere with the detection and management of suspected drug-related pulmonary toxicity
	Any active infection requiring systemic anti-infective therapy within 14 days prior to study drug administration
	Uncontrollable active infection(s)
	History of immunodeficiency, including HIV antibody positive
	active hepatitis B; or hepatitis C virus infections
	Has bleeding tendency
	History of severe cardiovascular diseases
	Known gastrointestinal diseases as follows, Gastrointestinal perforation, abdominal fistula or abdominal abscess within 6 months before signing the informed consent; History of poorly controlled or recurrent inflammatory bowel disease; Active peptic ulcers, or > moderate esophageal varices
	Pregnant or breastfeeding female

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A Study of HLX10 in Combination With Carboplatin Plus (+) Pemetrexed With or Without HLX04 Compared With Carboplatin+Pemetrexed in 1L Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)