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New treatment option for Non Small Cell Lung Cancer
Official title A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05913089
What this study is testing
What is TQB2450 injection + Chemotherapy?
TQB2450 injection + Chemotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a clinical study on the efficacy and safety of TQB2450 injection combined with chemotherapy or anlotinib hydrochloride capsule in the perioperative treatment of resectable non-small cell lung cancer. The part I study was planned to enroll 58 subjects, 1:1 randomized into two cohorts.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- patients with stage II-IIIB (T3N2M0 only) Non-Small Cell Lung Carcinoma (NSCLC) and determined to be eligible for curable R0 excision, after...
- ≥18 years old (calculated on the date of signing the informed consent); Both men and women; Eastern Cooperative Oncology Group (ECOG) score 0\~1...
- Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria within 28 days prior to initiation...
- 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.
You likely can't join if
- Present or complication with other malignancies within 5 years.
- people are known to have genetic abnormalities with approved targeted drug therapy.
- Cirrhosis, active hepatitis;
- Cardio-cerebrovascular abnormalities;
- people with severe active infection within 4 weeks prior to initiation of study treatment; Or unexplained fever \>38.0 ℃ occurred during screening...
- Patients with active tuberculosis within 1 year prior to enrollment;
See the full eligibility 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...
- The people voluntarily joined the study and signed the informed consent with good compliance.
- Present or complication with other malignancies within 5 years.
- people are known to have genetic abnormalities with approved targeted drug therapy.
- Cirrhosis, active hepatitis;
- Cardio-cerebrovascular abnormalities;
- people 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 compliance of patients to participate in this clinical study is estimated to be insufficient.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Weifang, Shandong, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Weifang, Shandong, China; Shanghai, Shanghai Municipality, China; Taiyuan, Shanxi, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.