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

A Phase II/III Clinical Study on the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Perioperative Treatment of Resectable Stage II/III Non Small Cell Lung Cancer.

This study is testing if adding a new drug called TQB2450 to chemotherapy or another treatment can help people with non-small cell lung cancer do better after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, anlotinib
• Locations: 10 sites (Beijing, Beijing Municipality and 9 other locations)
• Trial ID: NCT05913089 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stage II-IIIB non-small cell lung carcinoma eligible for curable surgery.

Not a fit: Patients with advanced non-small cell lung cancer or those who have previously received systemic antitumor therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could enhance the effectiveness of perioperative therapy for patients with non-small cell lung cancer.

How similar studies have performed: While similar approaches have been explored, this specific combination of TQB2450 with chemotherapy or anlotinib is relatively novel.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 9 other locations

• 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)
• Beijing Chest Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• Weifang People's Hospital — Weifang, Shandong, China (Recruiting)
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Tianjin Chest Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shugeng Gao, Doctor

Conditions Non Small Cell Lung Cancer