A Phase 3 interventional study of docetaxel and docetaxel in Carcinoma, Non-Small-Cell Lung, sponsored by Boehringer Ingelheim. Terminated at 13 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Boehringer Ingelheim · Phase 3, Interventional, and Treatment
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 12 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
patients to receive backbone chemotherapy and placebo
Drug: docetaxel · Drug: placebo
patients to receive backbone chemotherapy and nintedanib
Drug: docetaxel · Drug: nintedanib
intravenous chemotherapy drug
intravenous chemotherapy drug
oral placebo
oral experimental therapy
Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
Time frame: Up to 6 months.
| Milestone | Placebo | Nintedanib |
|---|---|---|
| Started | 6 | 6 |
| Completed | 0 | 0 |
| Not completed | 6 | 6 |
| Withdrew: Adverse event | 1 | 1 |
| Withdrew: Lack of efficacy | 4 | 3 |
| Withdrew: Withdrawal by subject | 1 | 2 |
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
| Percentage of participants | Placebo | Nintedanib |
|---|---|---|
| Yes | 66.7 | 50.0 |
| No | 33.3 | 50.0 |
Collected over From first drug administration until 28 days after last drug administration, up to 7 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 3/6 (50%) | 5/6 (83.3%) |
| Nintedanib | — | 3/6 (50%) | 6/6 (100%) |
| Event | Placebo | Nintedanib |
|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/6 | 0/6 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/6 | 1/6 |
| Atrial fibrillationCardiac disorders | 1/6 | 0/6 |
| Cardio-respiratory arrestCardiac disorders | 1/6 | 0/6 |
| TachycardiaCardiac disorders | 1/6 | 0/6 |
| Clostridium difficile infectionInfections and infestations | 1/6 | 0/6 |
| PneumoniaInfections and infestations | 1/6 | 1/6 |
| SepsisInfections and infestations | 0/6 | 1/6 |
| HypoglycaemiaMetabolism and nutrition disorders | 1/6 | 0/6 |
| Lactic acidosisMetabolism and nutrition disorders | 0/6 | 1/6 |
| Event | Placebo | Nintedanib |
|---|---|---|
| NauseaGastrointestinal disorders | 1/6 | 5/6 |
| VomitingGastrointestinal disorders | 0/6 | 5/6 |
| DiarrhoeaGastrointestinal disorders | 3/6 | 4/6 |
| FatigueGeneral disorders | 4/6 | 3/6 |
| Decreased appetiteMetabolism and nutrition disorders | 2/6 | 4/6 |
| NeutropeniaBlood and lymphatic system disorders | 2/6 | 3/6 |
| Abdominal painGastrointestinal disorders | 3/6 | 2/6 |
| Neuropathy peripheralNervous system disorders | 1/6 | 3/6 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 3/6 | 2/6 |
| AlopeciaSkin and subcutaneous tissue disorders | 3/6 | 2/6 |
Randomised Set: The randomised set included all randomised patients.
| Age, Continuous(Years) | Placebo | Nintedanib | Total |
|---|---|---|---|
| Mean | 59.7 ± 12.2 | 63.3 ± 8.3 | 61.5 ± 10.1 |
| Sex: Female, Male(Participants) | Placebo | Nintedanib | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 5 | 4 | 9 |
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Boehringer Ingelheim