Combining TQB2450 with chemotherapy or anlotinib for treating non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the efficacy and safety of TQB2450 injection when combined with either chemotherapy or anlotinib hydrochloride capsule in patients with resectable non-small cell lung cancer. The study involves two cohorts: one receiving TQB2450 with chemotherapy followed by surgery, and the other receiving TQB2450 with anlotinib before surgery. Patients will continue TQB2450 therapy for one year post-surgery. The study aims to determine the optimal treatment regimen for improving patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* patients with stage II-IIIB (T3N2M0 only) Non-Small Cell Lung Carcinoma (NSCLC) and determined to be eligible for curable R0 excision, after pathologic diagnosis of puncture specimens;
* ≥18 years old (calculated on the date of signing the informed consent); Both men and women; Eastern Cooperative Oncology Group (ECOG) score 0\~1; Predicted survival ≥3 months;
* Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria within 28 days prior to initiation of treatment;
* Has not received systemic antitumor therapy, including radiotherapy, chemotherapy and immunotherapy;
* Agree to provide fresh or 6 month tumor tissue for programmed death ligand -1 (PD-L1) testing.
* Major organs are functioning well.
* Women of reproductive age should agree that they must use effective birth control during the study period and for 6 months after the study, and that a negative serum or urine pregnancy test occurred within 7 days prior to study enrollment; Men should agree that effective contraception must be used during the study period and for 6 months after the study period ends.
* The subjects voluntarily joined the study and signed the informed consent with good compliance.

Exclusion Criteria:

* Present or complication with other malignancies within 5 years.
* Subjects are known to have genetic abnormalities with approved targeted drug therapy.
* Cirrhosis, active hepatitis;
* Cardio-cerebrovascular abnormalities;
* Subjects with severe active infection within 4 weeks prior to initiation of study treatment; Or unexplained fever \>38.0 ℃ occurred during screening and before first administration;
* Patients with active tuberculosis within 1 year prior to enrollment;
* Immunodeficiency disease;
* History of active autoimmune disease or autoimmune disease;
* Preparing for or having previously received an organ transplant, or having received a hematopoietic stem cell transplant within 60 days prior to initial medication, or having a significant host transplant response;
* Patients who required immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes and continued use within two weeks prior to randomization
* Severe infection of grade 4 or higher occurred within 1 year prior to initiation of study therapy;
* Severe lung disease;
* History of pituitary or adrenal dysfunction;
* History of severe mental disorder;
* History of drug abuse, alcoholism or drug use;
* Participated in clinical trials of other drugs within 30 days;
* History of live attenuated vaccine vaccination within 28 days prior to randomization or planned live attenuated vaccine vaccination during the study period;
* Received Chinese patent drugs with anti-tumor indications specified in the National Medical Product Administration approved drug package inserts within 2 weeks prior to initiation of administration
* Had major surgery within 4 weeks prior to initiation of medication;
* Other severe, acute, or chronic medical conditions or laboratory abnormalities that, in the investigator's opinion, may increase the risks associated with study participation or may interfere with the interpretation of the study results, or are otherwise unsuitable for participation in the clinical study;
* The compliance of patients to participate in this clinical study is estimated to be insufficient.

Where it's running

• Cancer Hospital of Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Beijing Chaoyang Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Weifang People's Hospital
  Weifang, Shandong, China Recruiting
• Shanxi Cancer Hospital
  Taiyuan, Shanxi, China Recruiting

Study contacts

• Study coordinator: Shugeng Gao, Doctor
• Email: 13901362568@139.com
• Phone: +86 13901362568

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining TQB2450 injection with Anlotinib and chemotherapy for advanced lung cancer

  This study is testing if adding a new injection called TQB2450 to Anlotinib and chemotherapy can help people with advanced lung cancer who haven't responded to earlier treatments.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.