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Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2/PHASE3

Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer

A Randomized, Controlled, Open-label Phase II/III Study of The Safety, Tolerability and Efficacy of JMT101 Combined With Docetaxel / HB1801 in Patients With sqNSCLC

NCT06319313•Shanghai JMT-Bio Inc.

View on ClinicalTrials.gov

Summary

This study is a phase II/III, randomized, controlled, open-label, multi-center study with safety run-in to evaluate the efficacy and safety of JMT101 combined with docetaxel/ HB1801 in Patients with Squamous cell non-small cell lung cancer （sqNSCLC）.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ranged from 18 to 75 years old (inclusive), regardless of gender;
•2. Pathological diagnosis as sqNSCLC, with EGFR highly expressed, without other driver genes
•3. Tumor tissue available for central laboratory testing;
•4. Disease progression after prior anti PD-1/PD-L1 and platinum containing chemotherapy
•5. Measurable disease according to RECIST1.1;
•6. Eastern Cooperative Oncology Group (ECOG) score 0-1 points;
•7. Life expectancy ≥3 months
•8. Adequate main organs and bone marrow function.
•9. Patients must give informed consent to this study before the experiment and voluntarily sign a written informed consent form.

Exclusion Criteria

•1. Previously used anti EGFR, or docetaxel;
•2. Central nervous system metastasis or meningeal metastasis;
•3. Patients with high risk of bleeding due to tumor invasion of important arteries;
•4. Uncontrolled or requiring repeated drainage of pleural effusion, pericardial effusion, or abdominal effusion;
•5. The adverse reactions of previous anti-tumor treatments (including radiotherapy) have not yet recovered to CTCAE 5.0 evaluation ≤ level 1 except for toxicity such as alocepia or fatigue, which is judged to be of no safety risk by researchers;
•6. Diagnosed as a second primary malignant tumor (except for skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ and breast carcinoma in situ, etc.) within 5 years prior to the first administration of the study drug;
•7. Have received anti-tumor treatments such as systemic chemotherapy, biological therapy, immunotherapy, radical radiotherapy chemotherapy, etc. within 28 days before the first dose of the study drug;
•8. Have undergone major surgery (excluding needle biopsy) or suffered severe traumatic injury within 28 days before the first dose of study drug;
•9. Have received a live viral vaccine or live-attenuated vaccine within 28 days before the first dose of study drug or plan to receive it during the study;
•10. Have received palliative radiotherapy, small molecule targeted therapy, immunomodulatory drugs, NMPA approved modern traditional Chinese medicine preparations and other anti-tumor treatments, within 14 days before the first dose of study drug;
+12 more criteria

Key Dates

Start Date

May 1, 2024

Primary Completion Date

July 1, 2026

Completion Date

December 1, 2027

Last Updated

March 20, 2024

Enrollment

534

ESTIMATED participants

Conditions

Squamous Cell Non-small Cell Lung Cancer

Interventions

JMT101

DRUG

docetaxel

DRUG

HB1801

DRUG

Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587 ctr-contact@cspc.cn

A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer

NCT02283320

KRAS Positive Patients With Non-small Cell Lung CancerSquamous Cell Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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