Last reviewed · How we verify

NCT03830411

A Study of Sintilimab Compared With Docetaxel or Pemetrexed as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy

Status unknown Phase 2 Last updated 8 November 2021
What this trial tests

Phase 2 trial testing Sintilimab in Nonsquamous Non-Small Cell Lung Cancer in 76 participants. Status unknown.

Timeline
13 March 2019
Primary endpoint
30 June 2022
30 June 2022

Quick facts

Lead sponsorXin-Hua Xu
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment76
Start date13 March 2019
Primary completion30 June 2022
Estimated completion30 June 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Xin-Hua Xu — full company profile →

Who can join

Adults 18 to 75, any sex, with Nonsquamous Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab compared with docetaxel or pemetrexed as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Revolutionization in Cancer Therapeutics via Targeting Major Immune Checkpoints PD-1, PD-L1 and CTLA-4.
    Pandey P, Khan F, Qari HA, Upadhyay TK, et al · · 2022 · cited 67× · PMID 35337133 · DOI 10.3390/ph15030335
  2. The progress and challenge of anti-PD-1/PD-L1 immunotherapy in treating non-small cell lung cancer.
    Qu J, Mei Q, Liu L, Cheng T, et al · · 2021 · cited 62× · PMID 33643442 · DOI 10.1177/1758835921992968
  3. Sintilimab for the treatment of non-small cell lung cancer.
    Zhang L, Lin W, Tan F, Li N, et al · · 2022 · cited 29× · PMID 35436956 · DOI 10.1186/s40364-022-00363-7

Verify or expand the search:

Other trials of Sintilimab

Trials testing the same drug.

Other Xin-Hua Xu trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03830411.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing