Trial · NCT02668393

Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

NCT02668393, Phase 1, Completed, Boehringer Ingelheim; results first posted 2021-01-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma. Trials, record NCT02668393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02668393

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
NCT number: NCT02668393
Status: Completed
Phases: Phase 1
Enrollment: 14 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Carcinoma, Non-Small-Cell Lung
Interventions: Docetaxel, Nintedanib, Nintedanib, Nintedanib, Nintedanib
First posted: 2016-01-29
Last updated: 2021-01-29
Other registries' IDs: eudract:2015-000317-52
Results first posted: 2021-01-29
Limitations and caveats: Recruitment was prematurely discontinued after dose level 2 (200 milligram) due to difficulties in recruiting subjects.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel	First treatment cycle, the first 28 days following the start of trial medication.	Maximum tolerated dose (MTD) of nintedanib administered in combination with docetaxel. The MTD was defined as the highest dose combination studied for which the incidence of DLTs was no more than 1 out of 6 subjects experiencing a DLT during the first treatment cycle i.e. the incidence of DLTs was no more than 17%. In case dose escalation reached dose level 3 (200 mg bid nintedanib administered without interruption on days of docetaxel infusion) and no more than 1 out of 6 subjects experienced a DLT during the first 28-day cycle at this dose level, dose level 3 was considered the MTD.
Primary	Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle	First treatment cycle, the first 28 days following the start of trial medication.	Number of participants with DLT occurring during the first treatment cycle. DLT was defined as any of the following adverse events related to nintedanib: * Non-haematological drug-related Common Terminology Criteria for AEs (CTCAE) grade 3 or greater * diarrhoea CTCAE grade 2 for \>7 days despite supportive care * nausea CTCAE grade 3 or greater despite supportive care * vomiting CTCAE grade 2 or greater despite supportive care * increase in Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) to CTCAE grade 3 or greater * A increase in ALT and/or AST to CTCAE grade 2 or greater in conjunction with * total bilirubin increase of CTCAE grade 1 or greater * Platelets \<50 000/mm3 with bleeding (CTCAE ≥3) * neutropenia of any grade or duration accompanied by fever \>38.5°C * neutropenia grade 4 without fever of \>7 days duration * Inability to resume nintedanib dosing within 21 days after stopping due to toxicity.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel	First treatment cycle, the first 28 days following the start of trial medication.	Maximum tolerated dose (MTD) Evaluation Set: All subjects who received at least one dose of study medication and were evaluable for MTD determination.	milligram	NUMBER
PRIMARY	Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle	First treatment cycle, the first 28 days following the start of trial medication.	Maximum tolerated dose (MTD) Evaluation Set: All subjects who received at least one dose of study medication and were evaluable for MTD determination.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel	Nintedanib + Docetaxel	NA	milligram
Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle	150 mg Nintedanib + Docetaxel	1	Participants
Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle	200 mg Nintedanib + Docetaxel	1	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	150 mg Nintedanib + Docetaxel	7
Overall Study	STARTED	200 mg Nintedanib + Docetaxel	7
Overall Study	COMPLETED	150 mg Nintedanib + Docetaxel	0
Overall Study	COMPLETED	200 mg Nintedanib + Docetaxel	1
Overall Study	NOT COMPLETED	150 mg Nintedanib + Docetaxel	7
Overall Study	NOT COMPLETED	200 mg Nintedanib + Docetaxel	6

Source ClinicalTrials.gov

Adverse events130

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	150 mg Nintedanib + Docetaxel	3	7
other	Anaemia	Blood and lymphatic system disorders	200 mg Nintedanib + Docetaxel	1	7
other	Leukopenia	Blood and lymphatic system disorders	150 mg Nintedanib + Docetaxel	1	7
other	Leukopenia	Blood and lymphatic system disorders	200 mg Nintedanib + Docetaxel	0	7
other	Neutropenia	Blood and lymphatic system disorders	150 mg Nintedanib + Docetaxel	1	7
other	Neutropenia	Blood and lymphatic system disorders	200 mg Nintedanib + Docetaxel	1	7
other	Lacrimation increased	Eye disorders	150 mg Nintedanib + Docetaxel	0	7
other	Lacrimation increased	Eye disorders	200 mg Nintedanib + Docetaxel	1	7
other	Vision blurred	Eye disorders	150 mg Nintedanib + Docetaxel	0	7
other	Vision blurred	Eye disorders	200 mg Nintedanib + Docetaxel	1	7

1 to 10 of 130Source ClinicalTrials.gov

See all 130 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	150 mg Nintedanib + Docetaxel	0	7
Total, all-cause mortality	200 mg Nintedanib + Docetaxel	0	7
Total, other adverse events	150 mg Nintedanib + Docetaxel	6	7
Total, other adverse events	200 mg Nintedanib + Docetaxel	6	7
Total, serious adverse events	150 mg Nintedanib + Docetaxel	3	7
Total, serious adverse events	200 mg Nintedanib + Docetaxel	2	7

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
150 mg Nintedanib + Docetaxel vs 200 mg Nintedanib + Docetaxel: deaths from any cause	Trial comparisons
150 mg Nintedanib + Docetaxel vs 200 mg Nintedanib + Docetaxel: Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle	Trial comparisons
150 mg Nintedanib + Docetaxel vs 200 mg Nintedanib + Docetaxel: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02668393

GET https://conductscience.org/api/trials/v1/NCT02668393/events?page=2

API reference For AI assistants