Non-small Cell Lung CancerPhase 2NCT03242915
Pembrolizumab Plus Chemotherapy in NSCLC With Targetable Genetic Alterations After Progression on Targeted Agents
A Phase 2 study testing Pembrolizumab, Carboplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 7 sites in United States.
Trial summary
Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of carboplatin and pemetrexed in patients with EGFR-mutation-positive NSCLC, or patients with other genetic alterations, and who have disease progression following appropriate targeted therapies. 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?
- Pembrolizumab, Carboplatin and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Oct 2017to 20 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cohort-specific:
- Cohort 1- EGFR mutation positive NSCLC patients previously treated with appropriate targeted therapy with progressive and measurable disease per RECIST 1.1 criteria tumor.
- Cohort 2- Other genetically altered NSCLC patients previously treated with appropriate targeted therapy with progressive and measurable tumor.
- Tumor tissue for PD-L1 assessment should be available unless PD-L1 assessment results are already available.
- Patients should not have received any systemic chemotherapy for advanced NSCLC. Patients who received 1 cycle of systemic chemotherapy for advanced NSCLC while awaiting the results of tumor molecular analysis and subsequently were switched to appropriate targeted therapy will be eligible. Patients who have received neoadjuvant, adjuvant or as part of concurrent chemotherapy and radiation are eligible if they received the chemotherapy 12 months or more before the start of study therapy.
- ECOG PS 0-1 (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.)
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- Patients should have recovered to ≤ grade 1 from clinically meaningful (example alopecia is not considered clinically meaningful) adverse events related to prior treatments.
- Patients should be willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Demonstrate adequate organ function
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 1 week of enrollment.
- Female subjects of childbearing potential must be willing to use an adequate method of contraception
- Male subjects of child bearing potential must agree to use an adequate method of contraception
Who cannot join
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. If the half-life of the drug is known then starting therapy 5 half-lives after the end of the last therapy is acceptable.
- Has a diagnosis of immunodeficiency. Patient should not be of any immunosuppressive therapy or steroids > prednisone 10mg/day or its equivalent on the day of the start of therapy.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab, carboplatin or pemetrexed or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had targeted small molecule therapy, or palliative radiation therapy within 1 week prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
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- Has a known additional malignancy that is progressing or requires active treatment or the treating physician believes will require therapy within 1 year.
- Has symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has known history of non-infectious pneumonitis that required steroids or has current pneumonitis. Has known history of interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Has known active Hepatitis B or Hepatitis C
- Has received a live vaccine within 30 days of planned start of study therapy.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Cancer Institute/Henry Ford Hospital
Detroit, Michigan, 48202
Sarah Cannon
Nashville, Tennessee, 37203
Montefiore Cancer Center
The Bronx, New York, 10467
About this study
Official title: Phase II Study of Pembrolizumab in Combination With Platinum-based Chemotherapy in Nonsmall Cell Lung Cancer Patients With Targetable Genetic Alterations Previously Treated With Appropriate Targeted Agents With Progressive Disease
Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of carboplatin and pemetrexed in patients with EGFR-mutation-positive NSCLC, or patients with other genetic alterations, and who have disease progression following appropriate targeted therapies.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Pembrolizumab, Carboplatin, Pemetrexed
- 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.
PembrolizumabDrug
200mg IV every 3 weeks
CarboplatinDrug
AUC 5 IV every 3 weeks
PemetrexedDrug
500 mg/m^2 IV every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab/Carboplatin/Pemetrexed | Experimental | Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients That Respond to Treatment
The primary endpoint is Response Rate (RR) defined as the rate of complete and partial response. Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis). Partial Response (PR): Persistence of one or more non-target lesion(s) but does not qualify for PD. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).
Measured: 5.5 years
Secondary outcomes (2)
Progression Free Survival (PFS) Time
PFS is defined as the duration of time from registration to time of progression. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).
Measured: 5.5 years
Overall Survival (OS) Time
Overall survival is defined as the time from registration to time of death. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive.
Measured: 5.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start3 Oct 2017
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Gregory Kalemkerian, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242915
- Sponsor's protocol ID
- UMCC 2017.057
- Other IDs
- HUM00129169
- Status last verified
- May 2025
- First submitted
- 3 Aug 2017
- Last updated
- 30 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pembrolizumab in Combination With Platinum-based Chemotherapy in Nonsmall Cell Lung Cancer Patients With Targetable Genetic Alterations Previously Treated With Appropriate Targeted Agents With Progressive Disease
- ClinicalTrials.gov ID
- NCT03242915
- Acronym / sponsor ID
- UMCC 2017.057
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 8 Aug 2017 (actual)
- Results
- Posted 30 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators hypothesize that addition of pembrolizumab will enhance the efficacy of carboplatin and pemetrexed in patients with EGFR-mutation-positive NSCLC, or patients with other genetic alterations, and who have disease progression following appropriate targeted therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab/Carboplatin/Pemetrexed | Experimental | Drug: Pembrolizumab, Drug: Carboplatin, Drug: PemetrexedPembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Cohort-specific:
- Cohort 1- EGFR mutation positive NSCLC patients previously treated with appropriate targeted therapy with progressive and measurable disease per RECIST 1.1 criteria tumor.
- Cohort 2- Other genetically altered NSCLC patients previously treated with appropriate targeted therapy with progressive and measurable tumor.
- Tumor tissue for PD-L1 assessment should be available unless PD-L1 assessment results are already available.
- Patients should not have received any systemic chemotherapy for advanced NSCLC. Patients who received 1 cycle of systemic chemotherapy for advanced NSCLC while awaiting the results of tumor molecular analysis and subsequently were switched to appropriate targeted therapy will be eligible. Patients who have received neoadjuvant, adjuvant or as part of concurrent chemotherapy and radiation are eligible if they received the chemotherapy 12 months or more before the start of study therapy.
Key exclusion criteria (18 listed)
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. If the half-life of the drug is known then starting therapy 5 half-lives after the end of the last therapy is acceptable.
- Has a diagnosis of immunodeficiency. Patient should not be of any immunosuppressive therapy or steroids > prednisone 10mg/day or its equivalent on the day of the start of therapy.
- Has a known history of active TB (Bacillus Tuberculosis)
- Hypersensitivity to pembrolizumab, carboplatin or pemetrexed or any of its excipients.
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
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 |
|---|---|---|
| Pembrolizumab200mg IV every 3 weeks | Drug | Pembrolizumab/Carboplatin/Pemetrexed |
| CarboplatinAUC 5 IV every 3 weeks | Drug | Pembrolizumab/Carboplatin/Pemetrexed |
| Pemetrexed500 mg/m^2 IV every 3 weeks | Drug | Pembrolizumab/Carboplatin/Pemetrexed |
Primary outcome
The Percentage of Patients That Respond to Treatment
Time frame: 5.5 years
The primary endpoint is Response Rate (RR) defined as the rate of complete and partial response. Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be non-pathological in size (<10mm short axis). Partial Response (PR): Persistence of one or more non-target lesion(s) but does not qualify for PD. Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).
2 secondary outcomes
Progression Free Survival (PFS) Time
Time frame: 5.5 years
Overall Survival (OS) Time
Time frame: 5.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gregory Kalemkerian, M.D. principal investigator
University of Michigan Rogel Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Carboplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 7 sites in United States.
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 13 inclusion and 18 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: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Patients That Respond to Treatment (time frame: 5.5 years). 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 30 May 2025.