Trial · NCT01244191
Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer
NCT01244191, Phase 3, Terminated, Daiichi Sankyo; results first posted 2020-10-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer. Trials, record NCT01244191. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01244191
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer
- NCT number
- NCT01244191
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,048 participants, actual
- Lead sponsor
- Daiichi Sankyo
- Conditions
- Non Squamous, Non-small-cell Lung Cancer
- Interventions
- Tivantinib, Placebo, Erlotinib
- First posted
- 2010-11-19
- Last updated
- 2021-04-06
- Other registries' IDs
- eudract:2010-022365-10
- Results first posted
- 2020-10-30
- Limitations and caveats
Based on the interim OS data, the study was terminated due to the protocol-defined stopping boundary for futility being met. The study would not meet its primary endpoint of improved OS in the ITT population. There were no safety concerns.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Date of randomization up to date of death, up to approximately 1 year 11 months postdose | The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause. |
| Secondary | Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose | Progression-free Survival (PFS) was defined as the time from the date of randomization to the date of the first objective documentation of disease progression or date of death from any cause (whichever comes first). As per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, progression was defined as at least a 20% increase in the sum of diameters of target lesions. |
| Secondary | Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC | Date of randomization up to date of death, up to approximately 1 year 11 months postdose | The overall survival (OS) was defined as the time from the date of randomization to the date of death from any cause. |
| Secondary | Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC | Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose | Progression-free Survival (PFS) was defined as the time from the date of randomization to the date of the first objective documentation of disease progression or date of death from any cause (whichever comes first). As per the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, progression was defined as at least a 20% increase in the sum of diameters of target lesions. |
| Secondary | Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to 1 year 11 months postdose | The best overall response was defined as the best response (in the order of confirmed complete response \[CR\], confirmed partial response \[PR\], stable disease \[SD\], and progressive disease \[PD\]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. If there was no tumor assessment after the first dose of study drug, the best overall response was classified as Inevaluable. Based on RECIST v1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. |
| Secondary | Duration of Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | From the date of first objective response (CR or PR) or SD to date of progressive disease, up to 1 year 11 months postdose | Duration of response was defined for participants with confirmed CR or PR as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progressive disease. Duration of SD was defined for participants whose best response was SD as the time from the randomization date to the date of the first documentation of progressive disease. |
| Secondary | Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer | Baseline up to 30 days after last dose, up to 1 year 11 months postdose | Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. |
| Secondary | Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC | Baseline up to 30 days after last dose, up to 1 year 11 months postdose | Treatment-emergent AEs (TEAEs) were defined as those AEs that occurred, having been absent before the study, or worsened in severity after the initiation of study treatment administration. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Date of randomization up to date of death, up to approximately 1 year 11 months postdose | Overall survival was assessed in the Intent-to-treat population. | months | MEDIAN |
| SECONDARY | Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose | Progression-free survival (PFS) was assessed in the Intent-to-treat population. | months | MEDIAN |
| SECONDARY | Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC | Date of randomization up to date of death, up to approximately 1 year 11 months postdose | Overall survival was assessed in participants with the epidermal growth factor receptor wild-type gene. | months | MEDIAN |
| SECONDARY | Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC | Date of randomization to disease progression or death (whichever comes first), up to 1 year 11 months postdose | Progression-free survival (PFS) was assessed in participants with the epidermal growth factor receptor wild-type gene. | months | MEDIAN |
| SECONDARY | Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | From baseline up to disease progression or the development of unacceptable toxicity (whichever occurs first), up to 1 year 11 months postdose | Best overall response was assessed in the Intent-to-treat population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | From the date of first objective response (CR or PR) or SD to date of progressive disease, up to 1 year 11 months postdose | Duration of response was assessed in the Intent-to-treat population. | weeks | MEDIAN |
| SECONDARY | Treatment-Emergent Adverse Events Reported in ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous, Non-Small-Cell Lung Cancer | Baseline up to 30 days after last dose, up to 1 year 11 months postdose | Adverse events were assessed in the Safety population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment-Emergent Adverse Events Related to Tivantinib/Placebo Experienced by ≥5% of Participants Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC | Baseline up to 30 days after last dose, up to 1 year 11 months postdose | Adverse events were assessed in the Safety population. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Tivantinib and Erlotinib | 8.5 | 95% Confidence Interval 7.1 to 9.3 | months | |
Overall Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Placebo and Erlotinib | 7.8 | 95% Confidence Interval 7.0 to 9.0 | months | |
Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Tivantinib and Erlotinib | 3.6 | 95% Confidence Interval 2.8 to 3.7 | months | |
Progression-free Survival Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Placebo and Erlotinib | 1.9 | 95% Confidence Interval 1.9 to 2.0 | months | |
Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC | Tivantinib and Erlotinib | 7.2 | 95% Confidence Interval 6.4 to 8.5 | months | |
Overall Survival in the Epidermal Growth Factor Receptor Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Non-Squamous NSCLC | Placebo and Erlotinib | 7.1 | 95% Confidence Interval 6.3 to 7.8 | months | |
Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC | Tivantinib and Erlotinib | 2.7 | 95% Confidence Interval 1.9 to 3.6 | months | |
Progression-free Survival in the Epidermal Growth Factor Receptor (EGFR) Gene Wild-Type Subpopulation Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants Non-Squamous NSCLC | Placebo and Erlotinib | 1.9 | 95% Confidence Interval 1.9 to 1.9 | months | |
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Tivantinib and Erlotinib | Complete response (CR) | 1 | Participants | |
Best Overall Tumor Response Following Treatment With Tivantinib (ARQ 197) Plus Erlotinib Compared to Placebo Plus Erlotinib in Previously Treated Participants With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer | Placebo and Erlotinib | Complete response (CR) | 1 | Participants |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tivantinib and Erlotinib | 526 | |
| Overall Study | STARTED | Placebo and Erlotinib | 522 | |
| Overall Study | Did Not Receive Treatment | Tivantinib and Erlotinib | 6 | |
| Overall Study | Did Not Receive Treatment | Placebo and Erlotinib | 5 | |
| Overall Study | COMPLETED | Tivantinib and Erlotinib | 46 | |
| Overall Study | COMPLETED | Placebo and Erlotinib | 24 | |
| Overall Study | NOT COMPLETED | Tivantinib and Erlotinib | 480 | |
| Overall Study | NOT COMPLETED | Placebo and Erlotinib | 498 |
Source ClinicalTrials.gov
Adverse events514
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 | Tivantinib and Erlotinib | 83 | 520 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo and Erlotinib | 51 | 517 | |
| other | Neutropenia | Blood and lymphatic system disorders | Tivantinib and Erlotinib | 62 | 520 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo and Erlotinib | 10 | 517 | |
| other | Abdominal pain | Gastrointestinal disorders | Tivantinib and Erlotinib | 34 | 520 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo and Erlotinib | 27 | 517 | |
| other | Abdominal pain, upper | Gastrointestinal disorders | Tivantinib and Erlotinib | 33 | 520 | |
| other | Abdominal pain, upper | Gastrointestinal disorders | Placebo and Erlotinib | 19 | 517 | |
| other | Constipation | Gastrointestinal disorders | Tivantinib and Erlotinib | 57 | 520 | |
| other | Constipation | Gastrointestinal disorders | Placebo and Erlotinib | 54 | 517 |
1 to 10 of 514Source ClinicalTrials.gov
See all 514 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tivantinib and Erlotinib | 77 | 520 |
| Total, all-cause mortality | Placebo and Erlotinib | 65 | 517 |
| Total, other adverse events | Tivantinib and Erlotinib | 513 | 520 |
| Total, other adverse events | Placebo and Erlotinib | 503 | 517 |
| Total, serious adverse events | Tivantinib and Erlotinib | 219 | 520 |
| Total, serious adverse events | Placebo and Erlotinib | 191 | 517 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tivantinib and Erlotinib vs Placebo and Erlotinib: deaths from any cause | Trial comparisons |
| Tivantinib and Erlotinib vs Placebo and Erlotinib: 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/NCT01244191
GET https://conductscience.org/api/trials/v1/NCT01244191/results?page=2