NCT05280873 is a Phase 1 clinical trial of Pirfenidone, methylprednisolone in Pneumonitis, sponsored by Zhou Chengzhi.

Who is sponsoring NCT05280873?

NCT05280873 is sponsored by Zhou Chengzhi.

What drugs are being tested in NCT05280873?

Interventions in NCT05280873: Pirfenidone, methylprednisolone, Methylprednisolone.

What condition does NCT05280873 study?

NCT05280873 studies Pneumonitis, Malignant Tumor.

Is NCT05280873 still recruiting?

NCT05280873 is currently status unknown. Last updated 15 March 2022.

Last reviewed 2022-03-15 · How we verify

NCT05280873

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

Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

Status unknown Phase 1 Last updated 15 March 2022

What this trial tests

Phase 1 trial testing Pirfenidone, methylprednisolone in Pneumonitis in 48 participants. Status unknown.

Timeline

10 October 2021

Primary endpoint
20 October 2023

20 October 2024

Quick facts

Lead sponsor	Zhou Chengzhi
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	10 October 2021
Primary completion	20 October 2023
Estimated completion	20 October 2024
Sites	1 location across China

Drugs / interventions tested

Pirfenidone, methylprednisolone — full drug profile →
Methylprednisolone (methylprednisolone) — full drug profile →

Conditions studied

Pneumonitis — all drugs for Pneumonitis →
Malignant Tumor — all drugs for Malignant Tumor →

Sponsor

Zhou Chengzhi — full company profile →

Who can join

Adults 18 to 75, any sex, with Pneumonitis or Malignant Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Checkpoint inhibitor-related pneumonitis (CIP）is a common fatal immune-related adverse event of PD-1/PD-L1 inhibitors. Some CIP patients have poor effect on hormone therapy, and the remission time of CIP varies greatly. Antifibrotic drugs may be effective in patients with CIP.

Publications & conference data

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

Anti‑PD‑1/PD‑L1 and anti‑CTLA‑4 associated checkpoint inhibitor pneumonitis in non‑small cell lung cancer: Occurrence, pathogenesis and risk factors (Review).
Hu X, Ren J, Xue Q, Luan R, et al · · 2023 · cited 12× · PMID 37681488 · DOI 10.3892/ijo.2023.5570
Chinese expert consensus on the multidisciplinary management of pneumonitis associated with immune checkpoint inhibitor.
Wang W, Wang Q, Xu C, Li Z, et al · · 2022 · cited 12× · PMID 36268845 · DOI 10.1111/1759-7714.14693
Targeting collagen to optimize cancer immunotherapy.
Wang Y, Zhang F, Qian Z, Jiang Y, et al · · 2025 · cited 7× · PMID 40721833 · DOI 10.1186/s40164-025-00691-y
Use of pirfenidone in fibrotic interstitial lung diseases and beyond: a review.
Han M, Liu Q, Ji Z, Jin L, et al · · 2024 · cited 5× · PMID 39165369 · DOI 10.3389/fmed.2024.1411279
Clinical management of checkpoint inhibitor pneumonitis: Focus, challenges, and future directions.
Xu Y, Chen R, Pan R, Gao X, et al · · 2025 · cited 4× · PMID 40226598 · DOI 10.1016/j.pccm.2024.12.001
Rheumatic adverse events of immune checkpoint inhibitors in cancer immunotherapy.
Abdel-Wahab N, Suarez-Almazor ME. · · 2024 · cited 4× · PMID 38400840 · DOI 10.1080/1744666x.2024.2323966
Expert consensus on cancer treatment-related lung injury.
Lin X, Guo H, Zhao W, Li M, et al · · 2025 · cited 2× · PMID 40400937 · DOI 10.21037/jtd-2025-292

Verify or expand the search:

Other recruiting trials for Pneumonitis

Currently open trials in the same condition.

NCT06860542 — Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis · Phase 2 · recruiting
NCT05455034 — Single-cell Sequencing of BLF to Guide the Treatment of Radiation Pneumonitis or Immune Checkpoint Inhibitor Pneumonitis · Phase 1, PHASE2 · recruiting

Other Zhou Chengzhi trials

Trials by the same sponsor.

NCT07340892 — Diagnostic Biomarkers for Checkpoint Inhibitor-related Pneumonitis · recruiting
NCT06462105 — Liposomal Irinotecan Combination Regimen for First-line Treatment of Small Cell Lung Cancer · NA · not yet recruiting
NCT04858828 — Investigation on Predictive Molecular Markers of Efficacy for Front-line Immunochemotherapy in Advanced NSCLC · unknown
NCT04310943 — Efficacy and Safety of Tislelizumab Combined With Bevacizumab and Albumin Paclitaxel in Lung Adenocarcinoma · Phase 2 · completed
NCT05001412 — Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of ES-SCLC · Phase 1 · unknown

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 NCT05280873 (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 Zhou Chengzhi
Last refreshed: 15 March 2022

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/NCT05280873.

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