Trial · NCT01199068
CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
NCT01199068, Phase 1, Completed, Daiichi Sankyo Co., Ltd.; results first posted 2020-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC). Trials, record NCT01199068. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01199068
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)
- NCT number
- NCT01199068
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- CS-7017, Erlotinib
- First posted
- 2010-09-10
- Last updated
- 2021-05-13
- Results first posted
- 2020-07-31
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | From post first dose to 30 days after last dose, up to approximately 1.5 years | A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. A CS-7017-related TEAE is an TEAE that is related to CS7017 in the relationship. |
| Primary | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer | Cycle 1, Week 1 and Cycle 2, Week 4 | After the first CS-7017 administration, area under the concentration-time curve from zero to the last quantifiable concentration (AUClast) and area under the concentration-time curve during dosing interval (AUCtau) were assessed. |
| Primary | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer | Cycle 1, Week 1 and Cycle 2, Week 4 | After the first CS-7017 administration, observed serum concentration (Cmax) and observed serum concentration at steady state (Cmax,ss) were assessed. |
| Primary | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer | Cycle 1, Week 1 and Cycle 2, Week 4 | After the first CS-7017 administration, time of maximum plasma concentration (Tmax) and time of maximum plasma concentration at steady state (Tmax,ss) were assessed. |
| Secondary | Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy | From screening and after completion of every 2 cycles (6 weeks) until disease progression, withdrawal of consent, death, or loss to follow-up, up to approximately 1.5 years | As per Response Evaluation Criteria for Solid Tumors v1.1, best overall response was characterized as complete response (CR) defined as disappearance of all target lesions, partial response (PR) defined as ≥30% decrease in the sum of diameters of target lesions, progressive disease (PD) defined as ≥20% increase in the sum of diameters of target lesions, and stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Response rate was defined as CR + PR. |
| Secondary | Progression-free Survival Time Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy | From randomization to PD or death, up to approximately 1.5 years | Progression-free survival (PFS) was defined as the time from randomization to the date of the first objective documentation of progressive disease (PD) or death resulting from any cause, whichever came first. |
| Secondary | Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | From post first dose to 30 days after last dose, up to approximately 1.5 years | A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. An erlotinib-related TEAE is an TEAE that is related to erlotinib in the relationship |
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 | CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | From post first dose to 30 days after last dose, up to approximately 1.5 years | CS-7017-related TEAEs were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer | Cycle 1, Week 1 and Cycle 2, Week 4 | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng*h/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter Observed Serum Concentration (Cmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer | Cycle 1, Week 1 and Cycle 2, Week 4 | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetic Parameter Time of Maximum Plasma Concentration (Tmax) of Serum Free Form of CS-7017 (R-150033) After CS-7017 and Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer | Cycle 1, Week 1 and Cycle 2, Week 4 | Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set. | h | MEDIAN |
| SECONDARY | Best Overall Response and Response Rate Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy | From screening and after completion of every 2 cycles (6 weeks) until disease progression, withdrawal of consent, death, or loss to follow-up, up to approximately 1.5 years | Best overall response and response rate were assessed in the Efficacy Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-free Survival Time Following Administration of CS-7017 in Combination With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy | From randomization to PD or death, up to approximately 1.5 years | Per-protocol Progression-free Survival Time data was only assessed in the 0.50 mg BID (additional portion) and the 0.5 mg BID (initial and additional portions) Groups. | days | MEDIAN |
| SECONDARY | Erlotinib-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | From post first dose to 30 days after last dose, up to approximately 1.5 years | Erlotinib-related TEAEs were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group379
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | CS-7017 0.25 mg BID; Initial Portion | At least one CS-7017-Relaed TEAE | 2 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | CS-7017 0.50 mg BID; Initial Portion | At least one CS-7017-Relaed TEAE | 2 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | CS-7017 0.50 mg BID; Additional Portion | At least one CS-7017-Relaed TEAE | 8 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | CS-7017 0.50 mg BID; Initial + Additional Portions | At least one CS-7017-Relaed TEAE | 10 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | Overall | At least one CS-7017-Relaed TEAE | 12 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | CS-7017 0.25 mg BID; Initial Portion | Blood and Lymphatic System Disorders | 1 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | CS-7017 0.50 mg BID; Initial Portion | Blood and Lymphatic System Disorders | 1 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | CS-7017 0.50 mg BID; Additional Portion | Blood and Lymphatic System Disorders | 4 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | CS-7017 0.50 mg BID; Initial + Additional Portions | Blood and Lymphatic System Disorders | 5 | Participants | |
CS-7017-Related Treatment-Emergent Adverse Events Occurring During the Study of Administration of CS-7017 Combined With Erlotinib in Participants With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer Who Failed First-line Therapy | Overall | Blood and Lymphatic System Disorders | 6 | Participants |
1 to 10 of 379Source ClinicalTrials.gov
See all 379 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CS-7017 0.25 mg BID; Initial Portion | 3 | |
| Overall Study | STARTED | CS-7017 0.50 mg BID; Initial Portion | 3 | |
| Overall Study | STARTED | CS-7017 0.50 mg BID; Additional Portion | 9 | |
| Overall Study | Received Treatment | CS-7017 0.25 mg BID; Initial Portion | 3 | |
| Overall Study | Received Treatment | CS-7017 0.50 mg BID; Initial Portion | 3 | |
| Overall Study | Received Treatment | CS-7017 0.50 mg BID; Additional Portion | 8 | |
| Overall Study | COMPLETED | CS-7017 0.25 mg BID; Initial Portion | 0 | |
| Overall Study | COMPLETED | CS-7017 0.50 mg BID; Initial Portion | 0 | |
| Overall Study | COMPLETED | CS-7017 0.50 mg BID; Additional Portion | 0 | |
| Overall Study | NOT COMPLETED | CS-7017 0.25 mg BID; Initial Portion | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events590
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 | Paronychia | Infections and infestations | CS-7017 0.25 mg BID; Initial Portion | 1 | 3 | |
| other | Paronychia | Infections and infestations | CS-7017 0.50 mg BID; Initial Portion | 0 | 3 | |
| other | Paronychia | Infections and infestations | CS-7017 0.50 mg BID; Additional Portion | 1 | 8 | |
| other | Paronychia | Infections and infestations | CS-7017 0.50 mg BID; Initial + Additional Portions | 1 | 11 | |
| other | Paronychia | Infections and infestations | Overall | 2 | 14 | |
| other | Pneumonia | Infections and infestations | CS-7017 0.25 mg BID; Initial Portion | 0 | 3 | |
| other | Pneumonia | Infections and infestations | CS-7017 0.50 mg BID; Initial Portion | 1 | 3 | |
| other | Pneumonia | Infections and infestations | CS-7017 0.50 mg BID; Additional Portion | 1 | 8 | |
| other | Pneumonia | Infections and infestations | CS-7017 0.50 mg BID; Initial + Additional Portions | 2 | 11 | |
| other | Pneumonia | Infections and infestations | Overall | 2 | 14 |
1 to 10 of 590Source ClinicalTrials.gov
See all 590 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CS-7017 0.25 mg BID; Initial Portion | 1 | 3 |
| Total, all-cause mortality | CS-7017 0.50 mg BID; Initial Portion | 1 | 3 |
| Total, all-cause mortality | CS-7017 0.50 mg BID; Additional Portion | 0 | 8 |
| Total, all-cause mortality | CS-7017 0.50 mg BID; Initial + Additional Portions | 1 | 11 |
| Total, all-cause mortality | Overall | 2 | 14 |
| Total, other adverse events | CS-7017 0.25 mg BID; Initial Portion | 3 | 3 |
| Total, other adverse events | CS-7017 0.50 mg BID; Initial Portion | 3 | 3 |
| Total, other adverse events | CS-7017 0.50 mg BID; Additional Portion | 8 | 8 |
| Total, other adverse events | CS-7017 0.50 mg BID; Initial + Additional Portions | 11 | 11 |
| Total, other adverse events | Overall | 14 | 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01199068
GET https://conductscience.org/api/trials/v1/NCT01199068/results?page=2