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
Phase 2 trial testing Sintilimab in Nonsquamous Non-Small Cell Lung Cancer in 76 participants. Status unknown.
30 June 2022
Quick facts
| Lead sponsor | Xin-Hua Xu |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 13 March 2019 |
| Primary completion | 30 June 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Sintilimab — full drug profile →
- Docetaxel (Docetaxel) — full drug profile →
- Pemetrexed — full drug profile →
Conditions studied
- Nonsquamous Non-Small Cell Lung Cancer — all drugs for Nonsquamous Non-Small Cell Lung Cancer →
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):
-
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 -
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 -
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:
- PubMed search for NCT03830411
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sintilimab
Trials testing the same drug.
- NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
- NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
- NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
- NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
- NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting
Other Xin-Hua Xu trials
Trials by the same sponsor.
- NCT06467500 — A Prospective, Open-label, Single-center, Single-arm Phase II Clinical Study of Cadonilimab (AK104) Combined With Monoth · Phase 2 · recruiting
- NCT05749042 — A Study of Concurrent Chemoradiotherapy Based of Cisplatin With or Without Sintilimab as First-line Therapy for Patients · Phase 2 · unknown
- NCT06029829 — The Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution. · Phase 2 · unknown
- NCT05792995 — Foundation and Clinical About the Expression of PD-1 in Peripheral Blood T Lymphocytes · Phase 2 · completed
- NCT04367909 — A Study of TC(Docetaxel and Carboplatin) Regimen With or Without Nimotuzumab in Recurrent Metastatic Oral Squamous Cell · Phase 2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03830411 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xin-Hua Xu
- Last refreshed: 8 November 2021
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