18 and older, any sex, with Recurrent Non-small Cell Lung Cancer or Squamous Cell Lung Cancer. 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.
6-month Progression Free Survival (PFS) Rate Within the Entire FGFR1 Amplified GroupPrimary· At 6 months
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Group
Value
95% CI
Treatment (Nintedanib)
0
0 – 65.8
Compare the 6-month PFS Rate for the Entire FGFR1 Amplified Group Versus the FGFR1 Non-amplified Patients.Secondary· Time from study entry to the first of either disease progression or death, assessed at 6 months
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.
Amplified
Group
Value
95% CI
Treatment (Nintedanib)
0
Non-amplified
Group
Value
95% CI
Treatment (Nintedanib)
0
Total
Group
Value
95% CI
Treatment (Nintedanib)
0
Compare the 6-month PFS Rate for Each FGFR1 Amplified Group (Low, Intermediate, and High) Versus FGFR1 Non-amplified Patients.Secondary· Time from study entry to the first of either disease progression or death, assessed at 6 months
The 6-month PFS rate was defined as the proportion of patients who were alive and progression-free at 6 months after start of study treatment.
Non-amplified
Group
Value
95% CI
Treatment (Nintedanib)
0
Intermediate amplification
Group
Value
95% CI
Treatment (Nintedanib)
0
High amplificiation
Group
Value
95% CI
Treatment (Nintedanib)
0
Total
Group
Value
95% CI
Treatment (Nintedanib)
0
Overall Survival (OS)Secondary· From study entry to death from any cause, assessed up to 3 years
Overall survival (OS) was defined as the time from study entry to death from any cause.
Amplified
Group
Value
95% CI
Treatment (Nintedanib)
10.2
4 – 16.4
Non-amplified
Group
Value
95% CI
Treatment (Nintedanib)
5.8
4.6 – 23.7
Overall
Group
Value
95% CI
Treatment (Nintedanib)
10.6
4 – 23.7
Tumor Response RateSecondary· Up to 3 years
Tumor Response rate was defined as the proportion of patients who had Complete Response (CR) or Partial Response (PR) by RECIST 1.1 Criteria. Complete Response (CR): Disappearance of all target lesions. Any lymph nodes must have a reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Amplified
Group
Value
95% CI
Treatment (Nintedanib)
0
0 – 66
Non-amplified
Group
Value
95% CI
Treatment (Nintedanib)
0
0 – 56
Total
Group
Value
95% CI
Treatment (Nintedanib)
0
0 – 39
Incidence of Adverse Events (AEs)Secondary· Up to 30 days post-treatment
Percentage of participants with adverse events. Incidence of Adverse Events (AEs) was Accessed by the National Cancer Institute (NCI) CTCAE Version 4.0.
Total
Group
Value
95% CI
Treatment (Nintedanib)
100
61 – 100
Amplified
Group
Value
95% CI
Treatment (Nintedanib)
100
34 – 100
Non-amplified
Group
Value
95% CI
Treatment (Nintedanib)
100
44 – 100
Progression Free SurvivalSecondary· Time from study entry to the first of either disease progression or death, assessed up to 3 years
Progression-free survival (PFS) was defined as the time from study entry to the first of either disease progression or death.
Overall
Group
Value
95% CI
Treatment (Nintedanib)
2.7
1.7 – 15.1
Amplified
Group
Value
95% CI
Treatment (Nintedanib)
1.8
1.8 – 1.9
Non-amplified
Group
Value
95% CI
Treatment (Nintedanib)
3.4
1.7 – 5.4
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well nintedanib works in treating patients with advanced non-small cell lung cancer who have failed up to two previous chemotherapy regimens. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03242759 — Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
· completed
NCT02788474 — Effect of Nintedanib on Biomarkers of Extracellular Matrix Turnover in Patients With Idiopathic Pulmonary Fibrosis and L
· Phase 4
· completed
Other recruiting trials for Recurrent Non-small Cell Lung Cancer
Currently open trials in the same condition.
NCT04623775 — A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as
· Phase 2
· active not recruiting
NCT01345851 — Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemother
· NA
· active not recruiting
Other Roswell Park Cancer Institute trials
Trials by the same sponsor.
NCT07489287 — GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer
· Phase 1
· not yet recruiting
NCT06943664 — Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-I
· Phase 2
· not yet recruiting
NCT06827054 — Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
· Phase 2
· not yet recruiting
NCT06334016 — Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
· EARLY_PHASE1
· not yet recruiting
NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma
· Phase 1
· withdrawn
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 Roswell Park Cancer Institute
Last refreshed: 8 June 2017
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/NCT01948141.