Clinical trial · Interventional
Evaluating Efficacy and Safety of Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer
Evaluating Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy Versus Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer: A Prospective, Randomized Controlled Phase II Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Clincal decision based on previous results
Summary
Brief summary (as posted)
This is a prospective, randomized, controlled phase II clinical study for evaluating anlotinib combined with concurrent chemoradiotherapy followed by consolidation immunotherapy versus concurrent chemoradiotherapy followed by consolidation immunotherapy in locally advanced, unresectable NSCLC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Efficacy and Safety | — | UNRESOLVED | — |
| Locally Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib | Drug | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Immunotherapy | Drug | Immunotherapy | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experiment group
- description
- Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy
- interventionNames
- Drug: Anlotinib
- Drug: Chemotherapy
- Radiation: Radiotherapy
- Drug: Immunotherapy
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy
- interventionNames
- Drug: Chemotherapy
- Radiation: Radiotherapy
- Drug: Immunotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * informed consent is required before proceeding with any steps in the study; * Male or female 18-75 years old; * Patients must be locally advanced, unresectable (stage IIIA-IIIC) with histology reported NSCLC (except for central squamous cell carcinoma or those at risk for massive hemoptysis); * No prior chemotherapy, immunotherapy, radiotherapy, surgery, or targeted therapy; * Tumor sample requirements: must provide sufficient evidence to allow analysis Stained, archived tumor tissue samples; * Life expectancy ≥ 12 weeks; * World Health Organization (WHO) PS score of 0 or 1; * Postmenopausal women, or negative urine or serum pregnancy test (HCG) within 14 days prior to study drug administration * Women of childbearing potential (WOCBP) must agree to adhere to contraceptive methods during study drug treatment and for 6 months after the last study drug treatment; * Men who have sex with WOCBP must agree to adhere to contraception during study drug treatment and for 6 months after the last study drug treatment; * azoospermic men do not have to adhere to contraceptive requirements. Adolescents of childbearing potential without heterosexual sex (WOCBP) do not have to comply with contraceptive requirements, but must still undergo a pregnancy test as described in this section; * Organ and bone marrow function meet the following conditions: Forced expiratory volume in 1 second (FEV1) ≥ 800ml; Absolute neutrophil count ≥1.5×10\^9/L; Platelet ≥100×10\^9/L; Hemoglobin ≥9.0g/dL; Serum creatinine clearance calculated according to Cockcroft-Gault formula ≥50 mL/ min (Cockcroft and Gault 1976); Serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN. Exclusion Criteria: * Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study; * Histological type of small cell lung cancer (including mixed small cell and non-small cell lung cancer); * Prior use of any targeted therapy; * The central cavity squamous cell carcinoma or non-small cell lung cancer with hemoptysis (the amount of hemoptysis\> 50 ml/d); * The patient has conditions that affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction, etc.) ; * Major surgery (excluding vascular access) within 4 weeks prior to study entry; * Heart rate-corrected mean QT interval (QTc) ≥ 470 ms, calculated from 3 electrocardiogram calculation cycles (ECG) using Bazett correction; * No Controlled complications, including but not limited to persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active hemorrhagic Illness, including any known HBsAg-positive patient with HBV DNA \> 500 IU/ml, Hepatitis C or Human Immunodeficiency Virus (HIV), or mental illness that would limit compliance with study requirements or impair the patient's ability to give written informed consent/ Social status; * History of another primary malignancy within 5 years prior to initiation of therapy, excluding adequately treated skin basal or squamous cell carcinoma or cervical carcinoma in situ; * Pregnant, breastfeeding women; Contraceptive method, male or female of reproductive potential; - Conditions that may interfere with the evaluation of the efficacy or safety of the treatment. * Patients who progressed after concurrent chemoradiotherapy; * History of tuberculosis, excluding old pulmonary tuberculosis; * Received live attenuated vaccine within 30 days before study initiation or within 30 days after tislelizide; * In Use of immunosuppressive drugs within 28 days prior to the first dose of tislelizumab. Of these, intranasal inhaled corticosteroids at physiological doses are excluded; prednisone or an equivalent amount of systemic corticosteroids not exceeding 10 mg per day is excluded. Steroids are permitted for management of chemoradiotherapy-related toxicity; * Patients with unrecovered CTCAE \> 2 toxicity after prior targeted combination chemoradiotherapy will be excluded from randomization; * due to prior targeted combined chemoradiotherapy, patients with grade ≥2 pneumonitis undergoing chemotherapy will be excluded from randomization.
References
Publications (14)
- RESULTBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
- RESULTFaivre-Finn C, Vicente D, Kurata T, Planchard D, Paz-Ares L, Vansteenkiste JF, Spigel DR, Garassino MC, Reck M, Senan S, Naidoo J, Rimner A, Wu YL, Gray JE, Ozguroglu M, Lee KH, Cho BC, Kato T, de Wit M, Newton M, Wang L, Thiyagarajah P, Antonia SJ. Four-Year Survival With Durvalumab After Chemoradiotherapy in Stage III NSCLC-an Update From the PACIFIC Trial. J Thorac Oncol. 2021 May;16(5):860-867. doi: 10.1016/j.jtho.2020.12.015. Epub 2021 Jan 19. PMID 33476803
- RESULTLin B, Song X, Yang D, Bai D, Yao Y, Lu N. Anlotinib inhibits angiogenesis via suppressing the activation of VEGFR2, PDGFRbeta and FGFR1. Gene. 2018 May 15;654:77-86. doi: 10.1016/j.gene.2018.02.026. Epub 2018 Feb 14. PMID 29454091
- RESULTPalakurthi S, Kuraguchi M, Zacharek SJ, Zudaire E, Huang W, Bonal DM, Liu J, Dhaneshwar A, DePeaux K, Gowaski MR, Bailey D, Regan SN, Ivanova E, Ferrante C, English JM, Khosla A, Beck AH, Rytlewski JA, Sanders C, Laquerre S, Bittinger MA, Kirschmeier PT, Packman K, Janne PA, Moy C, Wong KK, Verona RI, Lorenzi MV. The Combined Effect of FGFR Inhibition and PD-1 Blockade Promotes Tumor-Intrinsic Induction of Antitumor Immunity. Cancer Immunol Res. 2019 Sep;7(9):1457-1471. doi: 10.1158/2326-6066.CIR-18-0595. Epub 2019 Jul 22. PMID 31331945
- RESULTYang Y, Li L, Jiang Z, Wang B, Pan Z. Anlotinib optimizes anti-tumor innate immunity to potentiate the therapeutic effect of PD-1 blockade in lung cancer. Cancer Immunol Immunother. 2020 Dec;69(12):2523-2532. doi: 10.1007/s00262-020-02641-5. Epub 2020 Jun 23. PMID 32577817
- RESULTLiu S, Qin T, Liu Z, Wang J, Jia Y, Feng Y, Gao Y, Li K. anlotinib alters tumor immune microenvironment by downregulating PD-L1 expression on vascular endothelial cells. Cell Death Dis. 2020 May 4;11(5):309. doi: 10.1038/s41419-020-2511-3.