NCT04177290 is a Phase 1 clinical trial of Sintilimab (M1b) in Advanced or Metastatic NSCLC, sponsored by Innovent Biologics (Suzhou) Co. Ltd..

Who is sponsoring NCT04177290?

NCT04177290 is sponsored by Innovent Biologics (Suzhou) Co. Ltd..

What drugs are being tested in NCT04177290?

Interventions in NCT04177290: Sintilimab (M1b), Sintilimab (approved).

What condition does NCT04177290 study?

NCT04177290 studies Advanced or Metastatic NSCLC.

Is NCT04177290 still recruiting?

NCT04177290 is currently completed. Last updated 27 February 2023.

Last reviewed 2023-02-27 · How we verify

NCT04177290

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients

Completed Phase 1 Last updated 27 February 2023

What this trial tests

Phase 1 trial testing Sintilimab (M1b) in Advanced or Metastatic NSCLC in 48 participants. Completed in 4 September 2022.

Timeline

2 April 2020

Primary endpoint
28 February 2021

4 September 2022

Quick facts

Lead sponsor	Innovent Biologics (Suzhou) Co. Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	2 April 2020
Primary completion	28 February 2021
Estimated completion	4 September 2022
Sites	1 location across China

Drugs / interventions tested

Sintilimab (M1b) — full drug profile →
Sintilimab (approved) — full drug profile →

Conditions studied

Advanced or Metastatic NSCLC — all drugs for Advanced or Metastatic NSCLC →

Sponsor

Innovent Biologics (Suzhou) Co. Ltd. — full company profile →

Who can join

Adults 18 to 75, male only, with Advanced or Metastatic NSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Advanced or Metastatic NSCLC

Currently open trials in the same condition.

NCT05941897 — A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced · Phase 2 · active not recruiting
NCT05435248 — Phase 1/2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC) · Phase 1, PHASE2 · recruiting
NCT04612751 — Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-S · Phase 1 · active not recruiting
NCT04526691 — Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects Wi · Phase 1 · active not recruiting

Other Innovent Biologics (Suzhou) Co. Ltd. trials

Trials by the same sponsor.

NCT07502534 — A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers · Phase 1 · not yet recruiting
NCT07469800 — Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity · Phase 3 · not yet recruiting
NCT07473960 — IBI306 Monotherapy in Non-Familial Hypercholesterolemia and Mixed Hyperlipidemia · Phase 3 · recruiting
NCT07483567 — IBI343 in Combination With Sintilimab and SOX Regimen for Perioperative Treatment of Resectable, Locally Advanced Gastri · Phase 2 · not yet recruiting
NCT07483554 — IBI343 in Combination Therapy for Advanced Malignant Solid Tumors · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04177290 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Innovent Biologics (Suzhou) Co. Ltd.
Last refreshed: 27 February 2023

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/NCT04177290.

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