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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of 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.

A Clinical Study of TQB2450 Injection Combined With Chemotherapy or Anlotinib Hydrochloride Capsule in the Treatment of Non Small Cell Lung Cancer (NCT05913089) is a Phase 2 interventional studying Non Small Cell Lung Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. The treatment regimen was as follows: Cohort 1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6 weeks after the last administration, and TQB2450 therapy should be continued for 1 year after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochloride capsule. Surgery was performed 4-6 weeks after the last dose and continued for 1 year starting 4 weeks after surgery.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Non Small Cell Lung Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 58 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Non Small Cell Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form); 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 willing to sign a consent form with good compliance. Who Should NOT Join This Trial: - 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; - weakened immune system disease; - History of active autoimmune conditions (where your immune system attacks your own body) or autoimmune conditions (where your immune system attacks your own body); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

TQB2450 injection + Chemotherapy

TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Chemotherapy is a systematic treatment that kill fast growing cells.

DRUG

TQB2450 injection + Anlotinib Hydrochloride Capsule

TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand -1 (PD-L1). Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Locations (10)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05913089), the sponsor (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05913089 clinical trial studying?

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. The treatment regimen was as follows: Cohort 1: 3-4 cycles of TQB2450 combined with chemotherapy, surgery should be performed 4-6 weeks after the last administration, and TQB2450 therapy should be continued for 1 year after surgery. Cohort 2: 4 cycles of TQB2450 combined with 3 cycles of anlotinib hydrochl… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05913089?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05913089?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05913089. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05913089. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.