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NCT03884192: CONSIST

Consolidation Sintilimab After Concurrent Chemoradiation in Patients With Unresectable Stage III NSCLC

Status unknown Phase 3 Last updated 21 March 2019
What this trial tests

Phase 3 trial testing Consolidation Sintilimab in Carcinoma, Non-Small Cell Lung in 162 participants. Status unknown.

Timeline
12 December 2018
Primary endpoint
30 December 2020
30 December 2021

Quick facts

Lead sponsorShandong Cancer Hospital and Institute
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment162
Start date12 December 2018
Primary completion30 December 2020
Estimated completion30 December 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shandong Cancer Hospital and Institute

Who can join

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

Sponsor's own description

This is an open label, multi-center, randomized, control phase III trial, to compare the efficacy and safety of consolidation therapy with sintilimab (IBI308) versus best supported care (BSC), in unresectable stage III NSCLC patients who do not experience disease progression after initial concurrent chemoradiation.

Publications & conference data

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

  1. Recent updates on Sintilimab in solid tumor immunotherapy.
    Liu X, Yi Y. · · 2020 · cited 35× · PMID 33292551 · DOI 10.1186/s40364-020-00250-z
  2. Chemoradioimmunotherapy of inoperable stage III non-small cell lung cancer: immunological rationale and current clinical trials establishing a novel multimodal strategy.
    Käsmann L, Eze C, Taugner J, Roengvoraphoj O, et al · · 2020 · cited 26× · PMID 32646443 · DOI 10.1186/s13014-020-01595-3
  3. Treatment of stage III non-small cell lung cancer in the era of immunotherapy: pathological complete response to neoadjuvant pembrolizumab and chemotherapy.
    Yang ZR, Liu MN, Yu JH, Yang YH, et al · · 2020 · cited 12× · PMID 33209626 · DOI 10.21037/tlcr-20-896
  4. A Review of the Current Approach and Treatment Landscape for Stage III Non-Small Cell Lung Cancer.
    Sridhar A, Khan H, Yohannan B, Chan KH, et al · · 2024 · cited 5× · PMID 38731161 · DOI 10.3390/jcm13092633
  5. Evolving Therapeutic Scenario of Stage III Non-Small-Cell Lung Cancer.
    Baudoux N, Friedlaender A, Addeo A. · · 2023 · cited 5× · PMID 36818454 · DOI 10.1177/11795549231152948
  6. Immunotherapy progress and clinical strategy of unresectable locally advanced non-small cell lung cancer.
    Zhang X, Zhang J, Liu P, Wang J, et al · · 2023 · cited 4× · PMID 36845690 · DOI 10.3389/fonc.2023.1022042
  7. Drug development and evidence for lung cancer targeted therapy in Eastern Asia.
    Maggie Liu SY, Jin ZY, Deng JY, Zhong SM, et al · · 2024 · cited 2× · PMID 39381018 · DOI 10.1016/j.lanwpc.2024.101090
  8. [Combination of Radiation Therapy and Immunotherapy for Non-small Cell Lung Cancer: Peer Exchange on Frontier Academic Topics].
    Radiotherapy-Immunotherapy Discussion Group, Ai X, Cai Y, Chu Q, et al · · 2020 · cited 1× · PMID 32517461 · DOI 10.3779/j.issn.1009-3419.2020.102.24

Verify or expand the search:

Other recruiting trials for Carcinoma, Non-Small Cell Lung

Currently open trials in the same condition.

Other Shandong Cancer Hospital and Institute trials

Trials by the same sponsor.

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