Clinical trial · Interventional
Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC
Sintilimab Combined With Anlotinib Hydrochloride and Standard Platinum-Containing Dual-Agent Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment: A Single-Arm, Prospective and Exploratory Clinical Study
NCT04846452CI-TRIAL-00053230unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-arm, prospective, exploratory clinical study aiming to evaluate the efficacy and safety profile of sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens in advanced or metastatic NSCLC as first-line treatment. Totally 40 patients with negative driver genes (20 patients of squamous cell carcinoma, 20 patients of non-squamous cell carcinoma) are to be enrolled.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-Small Cell Squamous Lung Cancer | Lung Non-Small Cell Squamous Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin | Drug | — | UNRESOLVED |
| Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NSCLC patients with negative driver genes
- description
- Patients with negative driver genes advanced or metastatic NSCLC will receive sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens as first-line treatment.
- interventionNames
- Drug: Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin
- Drug: Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin
Primary outcomes (1)
- measure
- Object response rate (ORR)
- timeFrame
- Time Frame: Up to 24 moths.
- description
- Containing the incidence of complete response (CR) and partial response (PR).
Secondary outcomes (4)
- measure
- Progression-free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Voluntary provision of informed consent. * 2\. Males or females aged 18-75. * 3\. Histological or cytologically confirmed NSCLC, metastatic or recurrent (stage IV), non-resectable or radical radio-chemotherapy locally advanced (stage IIIB-IIIC). * 4\. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, or ROS1 gene mutation) * 5\. At least one lesion can be measured by imaging. * 6\. Have not received systemic treatment in the past. * 7\. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1. * 8\. Life expectancy ≥ 3 months. * 9\. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment. Exclusion Criteria: * 1\. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC. * 2\. Received radiation therapy within 6 weeks. * 3\. Diagnosed with other malignant diseases other than NSCLC within 5 years. * 4\. Have participated in other interventional clinical research treatments now or within 4 weeks. * 5\. Have previously received targeted therapy. * 6\. Received Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs within 2 weeks. * 7\. Have active autoimmune diseases requiring systemic treatment within 2 years. * 8\. Received systemic glucocorticoid therapy or immunosuppressive therapy within 7 days. * 9\. Clinically uncontrollable pleural effusion/abdominal effusion. * 10\. Known allogeneic organ transplantation or hematopoietic stem cell transplantation. * 11\. Known to be allergic to study drug. * 12\. Have been vaccinated with the live vaccine within 30 days. * 13\. Pregnant or breastfeeding females. * 14\. Other serious hazards to the safety of patients.
References
Publications (6)
- BACKGROUNDMcDermott DF, Atkins MB. PD-1 as a potential target in cancer therapy. Cancer Med. 2013 Oct;2(5):662-73. doi: 10.1002/cam4.106. Epub 2013 Jul 21. PMID 24403232
- 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
- RESULTTravis WD, Brambilla E, Nicholson AG, Yatabe Y, Austin JHM, Beasley MB, Chirieac LR, Dacic S, Duhig E, Flieder DB, Geisinger K, Hirsch FR, Ishikawa Y, Kerr KM, Noguchi M, Pelosi G, Powell CA, Tsao MS, Wistuba I; WHO Panel. The 2015 World Health Organization Classification of Lung Tumors: Impact of Genetic, Clinical and Radiologic Advances Since the 2004 Classification. J Thorac Oncol. 2015 Sep;10(9):1243-1260. doi: 10.1097/JTO.0000000000000630. PMID 26291008
- RESULTBarbee MS, Ogunniyi A, Horvat TZ, Dang TO. Current status and future directions of the immune checkpoint inhibitors ipilimumab, pembrolizumab, and nivolumab in oncology. Ann Pharmacother. 2015 Aug;49(8):907-37. doi: 10.1177/1060028015586218. Epub 2015 May 19. PMID 25991832
- RESULTGandhi L, Rodriguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16. PMID 29658856
- RESULTJiang S, Liang H, Liu Z, Zhao S, Liu J, Xie Z, Wang W, Zhang Y, Han B, He J, Liang W. The Impact of Anlotinib on Brain Metastases of Non-Small Cell Lung Cancer: Post Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303). Oncologist. 2020 May;25(5):e870-e874. doi: 10.1634/theoncologist.2019-0838. Epub 2020 Feb 20.