NCT03735628 is a Phase 1 clinical trial of Copanlisib in Non-small Cell Lung Cancer (NSCLC), sponsored by Bayer.

Who is sponsoring NCT03735628?

NCT03735628 is sponsored by Bayer.

What drugs are being tested in NCT03735628?

Interventions in NCT03735628: Copanlisib, Nivolumab.

What condition does NCT03735628 study?

NCT03735628 studies Non-small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC), Hepatocellular Carcinoma (HCC).

Is NCT03735628 still recruiting?

NCT03735628 is currently completed. Last updated 6 October 2023.

Last reviewed 2023-10-06 · How we verify

NCT03735628

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

An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors

Completed Phase 1 Last updated 6 October 2023

What this trial tests

Phase 1 trial testing Copanlisib in Non-small Cell Lung Cancer (NSCLC) in 16 participants. Completed in 13 October 2022.

Timeline

17 October 2018

Primary endpoint
13 October 2022

13 October 2022

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	17 October 2018
Primary completion	13 October 2022
Estimated completion	13 October 2022
Sites	6 locations across Canada, United States

Drugs / interventions tested

Copanlisib (COPANLISIB) — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Non-small Cell Lung Cancer (NSCLC) — all drugs for Non-small Cell Lung Cancer (NSCLC) →
Head and Neck Squamous Cell Carcinoma (HNSCC) — all drugs for Head and Neck Squamous Cell Carcinoma (HNSCC) →
Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer (NSCLC) or Head and Neck Squamous Cell Carcinoma (HNSCC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.

Publications & conference data

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

Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
Tumor-Associated Macrophages Regulate PD-1/PD-L1 Immunosuppression.
Pu Y, Ji Q. · · 2022 · cited 212× · PMID 35592338 · DOI 10.3389/fimmu.2022.874589
Neutrophils in the era of immune checkpoint blockade.
Faget J, Peters S, Quantin X, Meylan E, et al · · 2021 · cited 94× · PMID 34301813 · DOI 10.1136/jitc-2020-002242
Anti-EGFR therapy in metastatic colorectal cancer: mechanisms and potential regimens of drug resistance.
Li QH, Wang YZ, Tu J, Liu CW, et al · · 2020 · cited 75× · PMID 32665850 · DOI 10.1093/gastro/goaa026
Immune Checkpoint Inhibitors Combined with Targeted Therapy: The Recent Advances and Future Potentials.
Li B, Jin J, Guo D, Tao Z, et al · · 2023 · cited 66× · PMID 37345194 · DOI 10.3390/cancers15102858
Emerging Targeted Therapies in Advanced Non-Small-Cell Lung Cancer.
Li S, de Camargo Correia GS, Wang J, Manochakian R, et al · · 2023 · cited 47× · PMID 37296863 · DOI 10.3390/cancers15112899
Novel Systemic Treatment Modalities Including Immunotherapy and Molecular Targeted Therapy for Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma.
Ghosh S, Shah PA, Johnson FM. · · 2022 · cited 47× · PMID 35887235 · DOI 10.3390/ijms23147889
Clinical outcomes and influencing factors of PD-1/PD-L1 in hepatocellular carcinoma.
Wang J, Li J, Tang G, Tian Y, et al · · 2021 · cited 41× · PMID 33732355 · DOI 10.3892/ol.2021.12540

Verify or expand the search:

Other trials of Copanlisib

Trials testing the same drug.

NCT05082025 — Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K · Phase 2 · terminated
NCT04933617 — Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas · Phase 1 · terminated
NCT05010096 — BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors · Phase 1 · withdrawn
NCT04750941 — Study of Copanlisib and Ketogenic Diet · Phase 2 · terminated
NCT04572763 — Copanlisib Plus Venetoclax in R/R DLBCL · Phase 1, PHASE2 · active not recruiting

Other recruiting trials for Non-small Cell Lung Cancer (NSCLC)

Currently open trials in the same condition.

NCT07361497 — A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresec · Phase 3 · recruiting
NCT07288177 — Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · Phase 2 · recruiting
NCT07223047 — A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agent · Phase 1, PHASE2 · recruiting
NCT07291037 — Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic N · Phase 3 · recruiting
NCT07140016 — A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) · Phase 1 · recruiting

Other Bayer trials

Trials by the same sponsor.

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NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · 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 NCT03735628 (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 Bayer
Last refreshed: 6 October 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/NCT03735628.

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