Non-small Cell Lung CancerPhase 1NCT01836341
Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
A Phase 1 study testing Afatinib, Cisplatin and Carboplatin in people with Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center.
Trial summary
The purpose of this Phase I study is to test the safety of combining afatinib with standard chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Afatinib, Cisplatin and Carboplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable or inoperable, stage III or locoregional recurrence without evidence of distant, metastatic disease
- Pathologic confirmation of NSCLC at MSKCC
- Documentation of a sensitizing EGFR mutation
- Age ≥ 18 years
- No contraindication to definitive thoracic radiation therapy with concurrent chemotherapy
- Adequate organ function as defined by:
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- Calculated creatinine clearance≥ 45 mL/min (by Cockcroft-Gault)
- Total bilirubin less than 1.5 x ULN (unless known Gilbert's disease) and AST/ALT less than 3 x ULN
- Absolute neutrophil count greater than 1500/mm3
- Platelet count greater than 100,000/mm3
- Women of childbearing age must have a negative blood pregnancy test
- Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months there after
Who cannot join
- Prior chemotherapy or radiation therapy for this lung cancer (history of prior lung cancer that has been treated and deeded inactive by the clinician is acceptable)
- Ineligible for cisplatin or carboplatin per medical oncologist
- Ineligible for pemetrexed per medical oncologist
- Greater than minimal, exudative, or malignant pleural effusion
- Calculated creatinine clearance by Cockcroft \& Gault method ≤45 ml/min
- Unstable congestive heart failure
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- Ejection fraction <50% as assessed by MUGA or echocardiogram
- Interstitial lung disease
- Patient requiring on-going treatment with a potent inhibitor (cyclosporin, erythromycin, ketoconazole, itraconazole, quinidine, phenobarbital with quinidine, ritonavir, valspodar, verapamil) or inducer of P-gp (St. John's wort or rifampin)
- Women who are breastfeeding
About this study
Official title: A Dose-Finding Study Of Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
The purpose of this Phase I study is to test the safety of combining afatinib with standard chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This study will then test the safety of afatinib at different dose levels when combined with the chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given during radiation treatment and the drug afatinib will be continued after chemotherapy and radiation.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Afatinib, Cisplatin, Carboplatin, Pemetrexed, Radiation therapy
- Keywords
- Afatinib, Cisplatin, Carboplatin, Pemetrexed, Radiation therapy, EGFR mutation, 12-279
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
CisplatinDrug
CarboplatinDrug
PemetrexedDrug
Radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Afatinib w Cisplatin Pemetrexed Chemoradiation | Experimental | induction afatinib 40mg daily x 28days Cisplatin or Carboplatin (can be used if patient is not eligible for cisplatin) + Pemetrexed + 50Gy to pretreatment field boost to 60Gy to residual tumor + afatinib dose escalation*
*afatinib dose levels: 20mg daily, 30mg daily \& 40mg daily (3+3 design) Then adjuvant afatinib x 2 years Receives: Drug: Afatinib; Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
This will be defined as the dose at which fewer than 1:6 patients experiences a dose-limiting toxicity.
Measured: 1 year
Secondary outcomes (4)
local control rate
will be determined as the proportion of patients who start the concurrent phase who are alive and free of local failure.
Measured: at 1 year and at 2 years
tolerability of adjuvant afatinib
Tolerability will be defined by in terms of dose reductions, delays and discontinuations of patients who have not had disease progression or death.
Measured: at 3 months
median progression free survival
PFS is defined as the duration of time from start of treatment to time of progression of disease or death, whichever occurs first.
Measured: 2 years
median overall survival
will be calculated using Kaplan-Meier estimates among all patients enrolled.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Jamie E. Chaft, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836341
- Sponsor's protocol ID
- 12-279
- Status last verified
- Dec 2013
- First submitted
- 17 Apr 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Finding Study Of Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
- ClinicalTrials.gov ID
- NCT01836341
- Acronym / sponsor ID
- 12-279
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Afatinib, Cisplatin, Carboplatin, Pemetrexed, Radiation therapy, EGFR mutation, 12-279
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, National Comprehensive Cancer Network
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase I study is to test the safety of combining afatinib with standard chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This study will then test the safety of afatinib at different dose levels when combined with the chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given during radiation treatment and the drug afatinib will be continued after chemotherapy and radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib w Cisplatin Pemetrexed Chemoradiation | Experimental | Drug: Afatinib, Drug: Cisplatin, Drug: Carboplatin, Drug: Pemetrexed, Radiation: Radiation therapyinduction afatinib 40mg daily x 28days Cisplatin or Carboplatin (can be used if patient is not eligible for cisplatin) + Pemetrexed + 50Gy to pretreatment field boost to 60Gy to residual tumor + afatinib dose escalation* *afatinib dose levels: 20mg daily, 30mg daily \& 40mg daily (3+3 design) Then adjuvant afatinib x 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Unresectable or inoperable, stage III or locoregional recurrence without evidence of distant, metastatic disease
- Pathologic confirmation of NSCLC at MSKCC
- Documentation of a sensitizing EGFR mutation
- Age ≥ 18 years
- No contraindication to definitive thoracic radiation therapy with concurrent chemotherapy
Key exclusion criteria (10 listed)
- Prior chemotherapy or radiation therapy for this lung cancer (history of prior lung cancer that has been treated and deeded inactive by the clinician is acceptable)
- Ineligible for cisplatin or carboplatin per medical oncologist
- Ineligible for pemetrexed per medical oncologist
- Greater than minimal, exudative, or malignant pleural effusion
- Calculated creatinine clearance by Cockcroft \& Gault method ≤45 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinib | Drug | Afatinib w Cisplatin Pemetrexed Chemoradiation |
| Cisplatin | Drug | Afatinib w Cisplatin Pemetrexed Chemoradiation |
| Carboplatin | Drug | Afatinib w Cisplatin Pemetrexed Chemoradiation |
| Pemetrexed | Drug | Afatinib w Cisplatin Pemetrexed Chemoradiation |
| Radiation therapy | Radiation | Afatinib w Cisplatin Pemetrexed Chemoradiation |
Primary outcome
maximum tolerated dose
Time frame: 1 year
This will be defined as the dose at which fewer than 1:6 patients experiences a dose-limiting toxicity.
4 secondary outcomes
local control rate
Time frame: at 1 year and at 2 years
tolerability of adjuvant afatinib
Time frame: at 3 months
median progression free survival
Time frame: 2 years
median overall survival
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie E. Chaft, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afatinib, Cisplatin and Carboplatin in people with Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum tolerated dose (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.