18 and older, any sex, with Mesothelioma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-Free Survival (PFS)Primary· From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progr
Phase II
Group
Value
95% CI
Placebo
5.72
5.19 – 8.18
Nintedanib
9.36
5.55 – 12.65
Phase III
Group
Value
95% CI
Placebo
6.97
5.42 – 9.00
Nintedanib
6.77
5.36 – 9.07
Overall Survival (OS)Secondary· From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months)
Overall survival was defined as the duration of time from randomization to time of death.
This is the key secondary endpoint of the trial.
Phase II
Group
Value
95% CI
Placebo
14.46
10.41 – NA
Nintedanib
18.30
10.91 – NA
Phase III
Group
Value
95% CI
Placebo
16.07
9.66 – 19.29
Nintedanib
14.36
9.13 – 18.69
Objective Response According to Modified RECIST- Investigator AssessmentSecondary· Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months
Objective response (best overall tumour response of confirmed complete response \[CR\] or confirmed partial response \[PR\]).
Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement.
Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part.
Group
Value
95% CI
Placebo
42.8
36.3 – 49.5
Nintedanib
45.0
38.4 – 51.7
Disease Control According to Modified RECIST- Investigator AssessmentSecondary· Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months
Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST.
Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part.
Group
Value
95% CI
Placebo
92.6
88.4 – 95.6
Nintedanib
90.8
86.3 – 94.2
Adverse events — posted to ClinicalTrials.gov
Time frame: SAE & Non SAE: From first dose until 28 days (Phase II) or 30 days (Phase III) after last dose, up to approximately (approx.) 30 months in Phase II and approx. 32 months in Phase III. All-cause mortality: From randomization until end of follow-up, up to approx. 30 months in Phase II and approx. 32 months in Phase III.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu
· Phase 3
· recruiting
NCT07162961 — Nintedanib for Improving Reproductive Outcomes in Adenomyosis
· Phase 3
· not yet recruiting
NCT06297096 — Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease
· Phase 3
· recruiting
NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in
· Phase 1
· completed
NCT06643091 — Nintedanib Treatment in Unicentric Castleman Disease
· Phase 2
· not yet recruiting
Other recruiting trials for Mesothelioma
Currently open trials in the same condition.
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors
· Phase 1
· recruiting
NCT07126509 — Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma
· NA
· recruiting
NCT06503146 — 18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
· Phase 2
· recruiting
NCT06996249 — Prospective Data Collection Initiative on Thoracic Malignancies
· recruiting
NCT06885697 — Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Includi
· Phase 1
· recruiting
Other Boehringer Ingelheim trials
Trials by the same sponsor.
NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection
· not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a
· not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I
· Phase 3
· not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants
· Phase 1
· not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis
· Phase 3
· not yet recruiting
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 Boehringer Ingelheim
Last refreshed: 18 March 2019
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/NCT01907100.