Trial · NCT03157089
Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung
NCT03157089, Phase 2, Completed, Boehringer Ingelheim; results first posted 2021-02-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung. Trials, record NCT03157089. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03157089
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Afatinib in Combination With Pembrolizumab in Patients With Squamous Cell Carcinoma of the Lung
- NCT number
- NCT03157089
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Afatinib, pembrolizumab
- First posted
- 2017-05-17
- Last updated
- 2021-02-23
- Other registries' IDs
- eudract:2016-005042-37
- Results first posted
- 2021-02-23
- Limitations and caveats
After the safety run-in, the SMC decided that the benefit-risk ratio was not favorable and recommended ending the trial according to a protocol-defined option. Trial was completed as described in protocol.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 556 days. | Objective response rate is defined as percentage of participants with the best overall response of complete response (CR, disappearance of all target lesions) or confirmed partial response (PR, at least a 30% decrease in sum of diameter (SoD, longest diameter (LD) measured for all lesions except lymph nodes, where shortest diameter (ShD) was used) of target lesions, reference is baseline SoD). Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. |
| Secondary | Recommended Phase II Dose (RP2D) | 21 days (1 treatment cycle) from study treatment (afatinib and pembrolizumab) administration. | Recommended Phase II Dose (RP2D) was to be calculated through a Bayesian logistic regression model (BLRM) with overdose control that was to be fitted to binary toxicity outcomes. After 12 patients had completed at least one cycle (one cycle equals 21 days and consists of one time infusion of pembrolizumab at Day 1 + daily intake of afatinib) of treatment, the prior distributions were to be updated through Gibbs sampling procedures with the accumulated dose limiting toxicity (DLT) data from the first treatment cycle. The estimate of parameters was to be updated as data were accumulated using the BLRM. At the end of the dose confirmation, the toxicity probability at each dose level was to be calculated to determine an estimate of the RP2D. Posterior probabilities for the rate of DLT were to be summarised from BLRM. Confirmation of the RP2D by the Safety Monitoring Committee (SMC) was to be based on these probabilities as well as on the review of other safety and laboratory data. |
| Secondary | Disease Control Rate (DCR) | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 556 days. | Disease control rate was calculated as percentage of participants with CR, PR, or stable disease (SD, neither sufficient shrinkage to qualify for PR, taking as reference the baseline sum of diameters (SoD), nor sufficient increase to qualify for progressive disease (PD, at least a 20% increase in the SoD of target lesions, taking as reference the smallest SoD recorded on study (including baseline), together with an absolute increase in the SoD of at least 5 millimeter (mm ) or the appearance of one or more new lesions). Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. |
| Secondary | Duration of Objective Response (DOR) | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 436 days. | For participants who showed objective response, duration of objective response (DoR), was defined as the time from first documented complete response (CR) or partial response (PR) until the earliest of disease progression (PD) or death. Tumour response was assessed based on local radiological image (CT or MRI) evaluation by the investigators according to RECIST version 1.1. The number of participants with objective response who experienced the event "disease progression or death (whichever came first)" is reported instead of a metric summarizing the time-to-event data with unit of time, as the number analyzed was too small to perform a Kaplan-Meier-analysis. |
| Secondary | Progression-free Survival (PFS) | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 556 days. | Progression-free survival was defined as the time (weeks) from the date of the first afatinib or pembrolizumab administration to the date of disease progression (at least a 20% increase in the sum of diameter (SoD, longest diameter (LD) measured for all lesions except lymph nodes, where shortest diameter (ShD) was used) of target lesions, taking as reference the smallest SoD recorded on study (including baseline), together with an absolute increase in the SoD of at least 5 mm or the appearance of one or more new lesions) or death (if the patient died without progression). The date of progression for the primary analyses was determined based on investigator assessment. Tumour response was assessed based on local radiological image (Computerised tomography (CT) or Magnetic resonance imaging (MRI)) evaluation by the investigators according to RECIST version 1.1. Median and 95% Confidence Interval were calculated using Kaplan-Meier estimates. |
| Secondary | Overall Survival (OS) | From Day 1 of study treatment (afatinib or pembrolizumab) administration up to a total of 574 days. | Overall survival is defined as the time from the date of treatment start to the date of death from any cause. Participants without event were censored. Median and 95% Confidence Interval were calculated using Kaplan-Meier estimates. |
| Secondary | Tumour Shrinkage | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 556 days. | Tumour shrinkage (in millimeters) is defined as the difference between the minimum post-baseline sum of diameters of target lesions (SoD, longest for non-nodal lesions, short axis for nodal lesions) and the baseline sum of diameters of the same set of target lesions. Tumour shrinkage is reported as percentage change from baseline and represents the maximum decrease or the minimum increase from baseline in SoD in percentage of the baseline SoD. Negative values indicate a reduction in the SoD; positive values indicate an increase in the SoD. Tumour response was assessed based on local radiological image (CT or MRI) evaluation by the investigators according to RECIST 1.1. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 556 days. | The treated set (TS) included all participants, who received at least one dose of afatinib or pembrolizumab. | Percentage of Participants | NUMBER |
| SECONDARY | Recommended Phase II Dose (RP2D) | 21 days (1 treatment cycle) from study treatment (afatinib and pembrolizumab) administration. | The treated set (TS) included all participants, who received at least one dose of afatinib or pembrolizumab. Because the Safety Monitoring Committee (SMC) decided that the benefit-risk ratio of afatinib in combination with pembrolizumab was not favorable, the trial was stopped according to a protocol-defined option and the decision on RP2D was not performed. | Milligramm (mg) | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 556 days. | The treated set (TS) included all participants who received at least one dose of afatinib or pembrolizumab. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 436 days. | All participants who received at least one dose of afatinib or pembrolizumab and showed objective response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival (PFS) | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 556 days. | The treated set (TS) included all participants, who received at least one dose of afatinib or pembrolizumab. | weeks | MEDIAN |
| SECONDARY | Overall Survival (OS) | From Day 1 of study treatment (afatinib or pembrolizumab) administration up to a total of 574 days. | The treated set (TS) included all participants, who received at least one dose of afatinib or pembrolizumab. | weeks | MEDIAN |
| SECONDARY | Tumour Shrinkage | Tumour assessment performed at screening (-28 days), week 9 (day 56-63) after study treatment (afatinib or pembrolizumab) start and every 9th week thereafter, up to 556 days. | The treated set (TS) included all participants, who received at least one dose of afatinib or pembrolizumab. | Percentage change | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Afatinib 40 mg + Pembrolizumab 200 mg | 16.7 | Percentage of Participants | ||
| Objective Response Rate (ORR) | Afatinib 30 mg + Pembrolizumab 200 mg | 8.3 | Percentage of Participants | ||
| Recommended Phase II Dose (RP2D) | Afatinib + Pembrolizumab | NA | Milligramm (mg) | ||
| Disease Control Rate (DCR) | Afatinib 40 mg + Pembrolizumab 200 mg | 50 | Percentage of participants | ||
| Disease Control Rate (DCR) | Afatinib 30 mg + Pembrolizumab 200 mg | 58.3 | Percentage of participants | ||
| Duration of Objective Response (DOR) | Afatinib 40 mg + Pembrolizumab 200 mg | 2 | Participants | ||
| Duration of Objective Response (DOR) | Afatinib 30 mg + Pembrolizumab 200 mg | 1 | Participants | ||
| Progression-free Survival (PFS) | Afatinib 40 mg + Pembrolizumab 200 mg | 9.0 | 95% Confidence Interval 4.6 to 27.1 | weeks | |
| Progression-free Survival (PFS) | Afatinib 30 mg + Pembrolizumab 200 mg | 14.4 | 95% Confidence Interval 5.0 to 26.1 | weeks | |
| Overall Survival (OS) | Afatinib 40 mg + Pembrolizumab 200 mg | 37.9 | 95% Confidence Interval 15.0 to 59.3 | weeks |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Afatinib 40 mg + Pembrolizumab 200 mg | 12 | |
| Overall Study | STARTED | Afatinib 30 mg + Pembrolizumab 200 mg | 12 | |
| Overall Study | Treated | Afatinib 40 mg + Pembrolizumab 200 mg | 12 | |
| Overall Study | Treated | Afatinib 30 mg + Pembrolizumab 200 mg | 12 | |
| Overall Study | COMPLETED | Afatinib 40 mg + Pembrolizumab 200 mg | 0 | |
| Overall Study | COMPLETED | Afatinib 30 mg + Pembrolizumab 200 mg | 0 | |
| Overall Study | NOT COMPLETED | Afatinib 40 mg + Pembrolizumab 200 mg | 12 | |
| Overall Study | NOT COMPLETED | Afatinib 30 mg + Pembrolizumab 200 mg | 12 |
Source ClinicalTrials.gov
Adverse events216
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 | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Afatinib 40 mg + Pembrolizumab 200 mg | 3 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Afatinib 30 mg + Pembrolizumab 200 mg | 3 | 12 | |
| other | Atrial fibrillation | Cardiac disorders | Afatinib 40 mg + Pembrolizumab 200 mg | 1 | 12 | |
| other | Atrial fibrillation | Cardiac disorders | Afatinib 30 mg + Pembrolizumab 200 mg | 0 | 12 | |
| other | Hyperthyroidism | Endocrine disorders | Afatinib 40 mg + Pembrolizumab 200 mg | 2 | 12 | |
| other | Hyperthyroidism | Endocrine disorders | Afatinib 30 mg + Pembrolizumab 200 mg | 2 | 12 | |
| other | Hypothyroidism | Endocrine disorders | Afatinib 40 mg + Pembrolizumab 200 mg | 0 | 12 | |
| other | Hypothyroidism | Endocrine disorders | Afatinib 30 mg + Pembrolizumab 200 mg | 2 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Afatinib 40 mg + Pembrolizumab 200 mg | 1 | 12 | |
| other | Abdominal pain | Gastrointestinal disorders | Afatinib 30 mg + Pembrolizumab 200 mg | 1 | 12 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Afatinib 40 mg + Pembrolizumab 200 mg | 10 | 12 |
| Total, all-cause mortality | Afatinib 30 mg + Pembrolizumab 200 mg | 10 | 12 |
| Total, other adverse events | Afatinib 40 mg + Pembrolizumab 200 mg | 12 | 12 |
| Total, other adverse events | Afatinib 30 mg + Pembrolizumab 200 mg | 12 | 12 |
| Total, serious adverse events | Afatinib 40 mg + Pembrolizumab 200 mg | 4 | 12 |
| Total, serious adverse events | Afatinib 30 mg + Pembrolizumab 200 mg | 9 | 12 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Afatinib 40 mg + Pembrolizumab 200 mg vs Afatinib 30 mg + Pembrolizumab 200 mg: Duration of Objective Response (DOR) | Trial comparisons |
| Afatinib 40 mg + Pembrolizumab 200 mg vs Afatinib 30 mg + Pembrolizumab 200 mg: deaths from any cause | Trial comparisons |
| Afatinib 40 mg + Pembrolizumab 200 mg vs Afatinib 30 mg + Pembrolizumab 200 mg: 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.
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/NCT03157089
GET https://conductscience.org/api/trials/v1/NCT03157089/events?page=2