Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC

NCT04846452 | Unknown Phase 2

• 1 other identifier: 2021-SR-088
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Metastatic NSCLC; Recurrent NSCLC; Advanced Non-Small Cell Squamous Lung Cancer

Keywords

Metastatic NSCLC; Recurrent NSCLC; Advanced NSCLC; Sintilimab; Anlotinib Hydrochloride; Chemotherapy; First-Line Treatment

Outcome Measures

Primary Outcomes (1)

• Object response rate (ORR)

  Containing the incidence of complete response (CR) and partial response (PR).

  Time Frame: Up to 24 moths.

Secondary Outcomes (4)

• Progression-free survival (PFS)

  Up to 24 months.

• Disease control rate (DCR)

  Up to 24 months.

• Duration of Remission (DOR)

  Up to 24 months.

• Overall survival (OS)

  Up to 24 months.

Study Arms (1)

NSCLC patients with negative driver genes

EXPERIMENTAL

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.

Drug: Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin; Drug: Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin

Interventions

Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin DRUG

Patients with non-squamous NSCLC will receive sintilimab, anlotinib hydrochloride, pemetrexed, and cisplatin or carboplatin.

Also known as: combination therapy

NSCLC patients with negative driver genes

Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin DRUG

Patients with squamous NSCLC will receive sintilimab, anlotinib hydrochloride, albumin paclitaxel, and carboplatin.

Also known as: combination therapy

NSCLC patients with negative driver genes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntary provision of informed consent.
• \. Males or females aged 18-75.
• \. Histological or cytologically confirmed NSCLC, metastatic or recurrent (stage IV), non-resectable or radical radio-chemotherapy locally advanced (stage IIIB-IIIC).
• \. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, or ROS1 gene mutation)
• \. At least one lesion can be measured by imaging.
• \. Have not received systemic treatment in the past.
• \. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
• \. Life expectancy ≥ 3 months.
• \. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

You may not qualify if:

• \. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
• \. Received radiation therapy within 6 weeks.
• \. Diagnosed with other malignant diseases other than NSCLC within 5 years.
• \. Have participated in other interventional clinical research treatments now or within 4 weeks.
• \. Have previously received targeted therapy.
• \. Received Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs within 2 weeks.
• \. Have active autoimmune diseases requiring systemic treatment within 2 years.
• \. Received systemic glucocorticoid therapy or immunosuppressive therapy within 7 days.
• \. Clinically uncontrollable pleural effusion/abdominal effusion.
• \. Known allogeneic organ transplantation or hematopoietic stem cell transplantation.
• \. Known to be allergic to study drug.
• \. Have been vaccinated with the live vaccine within 30 days.
• \. Pregnant or breastfeeding females.
• \. Other serious hazards to the safety of patients.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (6)

• McDermott 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 BACKGROUND

• Bray 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 RESULT

• Travis 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 RESULT

• Barbee 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 RESULT

• Gandhi 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 RESULT

• Jiang 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.

  PMID: 32077550 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; anlotinib; Pemetrexed; Cisplatin; Carboplatin; Combined Modality Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Therapeutics

Study Officials

• Lingxiang Liu, Physician

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lingxiang Liu, Physician

CONTACT

(+86) 13851892074; llxlau@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 15, 2021
• Study Start: June 1, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication.
• Access Criteria: IPD will be shared with other related clinical trials or systematic reviews after reviewing requests by the chief investigator and examiners.

Locations

CN (1)