Stage IV Non-small Cell Lung CancerPhase 1/2NCT03559049
Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer
A Phase 1/2 study testing Pembrolizumab, Pemetrexed and Carboplatin in people with Stage IV Non-small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 3 sites in United States.
Trial summary
This study is a multi-center, Phase I/II, single arm trial to assess the safety and efficacy of the combination of oral rucaparib plus intravenous pembrolizumab as maintenance therapy in patients with stage IV non-squamous non-small cell lung cancer (NSCLC) without progressive disease (PD), as confirmed on CT scans… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Non-small Cell Lung Cancer
- What is being tested?
- Pembrolizumab, Pemetrexed and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Dec 2018to 1 May 2025
- Phase
- Phase 1/2
- 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
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥18 years of age on day of signing informed consent.
- Have a life expectancy of at least 3 months.
- Have a diagnosis of stage IV non-squamous NSCLC whose tumors do not have an epidermal sensitizing growth factor (EGFR) mutation or BRAF mutation or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1 and have at least one measurable lesion based on RECIST v1.1.
- Have a performance status of 0 or 1 on the ECOG Performance Scale (Appendix 15.1).
- Demonstrate adequate organ function
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- Female subject of childbearing potential should have a serum pregnancy test within -28 days of enrollment and 72 hours prior to receiving the first dose of study medications.
- Female subjects of childbearing potential must be willing to use a highly effective method of contraception as outlined in Section 6.3.3 for the course of the study through 180 days after the last dose of study medications. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 6.3.3, starting with the first dose of study therapy through 180 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- If the patient has archival tissue, this should be collected for correlative studies. If archival tissue does not exist, a new biopsy is not required
Who cannot join
- Received previous systemic therapy for stage IV NSCLC
- Received radiation to the lungs >30Gy ≤6 months of enrollment
- Received palliative radiation within 7 days of enrollment
- Had prior treatment with any other anti-PD-1, PD-L1, or PD-L2 agent or an antibody targeting other immune-regulatory receptors or mechanisms
- Received prior treatment with a PARP inhibitor
- Has a known history of prior malignancy except if the patient has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy
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- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has active autoimmune disease that has required systemic treatment within the past 2 years
- Subjects requiring daily corticosteroids >10mg of prednisone (or its equivalent) would be excluded from the study.
- Has evidence of interstitial lung disease or a history of non-infectious pneumonitis that required oral or intravenous glucocorticoids to assist with management
- Has an active infection requiring systemic therapy
- 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 informed consent through 180 days after the last dose of trial treatment
- Has a diagnosis of immunodeficiency (including Human Immunodeficiency Virus (HIV) or acquired immunodeficiency (AIDS)-related illness) or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment
- Has a known history of active TB (Bacillus Tuberculosis)
- Has known active Hepatitis B or Hepatitis C
- Has received a live vaccine within 30 days of enrollment
- A medical condition that requires daily systemic corticosteroids, greater than the equivalent of 10mg of prednisone
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase I/II Multi-site Study of Rucaparib and Pembrolizumab Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer After Initial Therapy With Carboplatin, Pemetrexed, and Pembrolizumab
This study is a multi-center, Phase I/II, single arm trial to assess the safety and efficacy of the combination of oral rucaparib plus intravenous pembrolizumab as maintenance therapy in patients with stage IV non-squamous non-small cell lung cancer (NSCLC) without progressive disease (PD), as confirmed on CT scans, after induction therapy with carboplatin/pemetrexed/pembrolizumab (CPP) triplet therapy.
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Being tested
- Pembrolizumab, Pemetrexed, Carboplatin, Rucaparib
- 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 21 days
PemetrexedDrug
500mg/m^2 IV every 21 days
CarboplatinDrug
AUC 5 IV every 21 days
RucaparibDrug
600mg PO, BID days 1-21 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Rucaparib and Pembrolizumab Maintenance | Experimental | All patients will receive induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days).
This will be followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle). Receives: Drug: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Rucaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Duration of Time From Start of Treatment to Time of Progression
The primary endpoint is median progression free survival (PFS) which is defined as the median duration of time from the start of treatment to progression. Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
Measured: Up to 5 years
Secondary outcomes (2)
Median Duration of Time From the Start of Treatment Until Death
The secondary endpoint is median overall survival (OS) which is defined as the median duration of time from the start of treatment until death.
Measured: Up to 5 years
Response Rate
Percentage of patients who achieve a complete or partial response after at least one cycle of maintenance therapy with rucaparib and pembrolizumab. Response assessed by immune-related Response Evaluation Criteria in Solid Tumors (irRecist).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start24 Dec 2018
- Primary completion1 May 2025
- Study completion1 May 2025
Why it stopped: Due to financial hardships suffered by the stakeholder
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 Stage IV 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Clovis Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Angel Qin, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559049
- Sponsor's protocol ID
- UMCC 2018.033
- Other IDs
- HUM00142973
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2018
- Last updated
- 12 Feb 2026
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Multi-site Study of Rucaparib and Pembrolizumab Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer After Initial Therapy With Carboplatin, Pemetrexed, and Pembrolizumab
- ClinicalTrials.gov ID
- NCT03559049
- Acronym / sponsor ID
- UMCC 2018.033
- Conditions
- Stage IV Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to financial hardships suffered by the stakeholder
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Clovis Oncology, Inc.
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multi-center, Phase I/II, single arm trial to assess the safety and efficacy of the combination of oral rucaparib plus intravenous pembrolizumab as maintenance therapy in patients with stage IV non-squamous non-small cell lung cancer (NSCLC) without progressive disease (PD), as confirmed on CT scans, after induction therapy with carboplatin/pemetrexed/pembrolizumab (CPP) triplet therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rucaparib and Pembrolizumab Maintenance | Experimental | Drug: Pembrolizumab, Drug: Pemetrexed, Drug: Carboplatin, Drug: RucaparibAll patients will receive induction therapy with Pembrolizumab (200mg IV on day 1 of every 21 days), Pemetrexed (500mg/m^2 IV on day 1 of every 21 days), and Carboplatin (AUC5 IV on day 1 of every 21 days). This will be followed by maintenance therapy with Pembrolizumab (200mg IV on day 1 of every 21 days) and Rucaparib (600mg PO BID days 1-21 of each 21 day cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥18 years of age on day of signing informed consent.
- Have a life expectancy of at least 3 months.
- Have a diagnosis of stage IV non-squamous NSCLC whose tumors do not have an epidermal sensitizing growth factor (EGFR) mutation or BRAF mutation or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1 and have at least one measurable lesion based on RECIST v1.1.
- Have a performance status of 0 or 1 on the ECOG Performance Scale (Appendix 15.1).
Key exclusion criteria (18 listed)
- Received previous systemic therapy for stage IV NSCLC
- Received radiation to the lungs >30Gy ≤6 months of enrollment
- Received palliative radiation within 7 days of enrollment
- Had prior treatment with any other anti-PD-1, PD-L1, or PD-L2 agent or an antibody targeting other immune-regulatory receptors or mechanisms
- Received prior treatment with a PARP inhibitor
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 21 days | Drug | Rucaparib and Pembrolizumab Maintenance |
| Pemetrexed500mg/m^2 IV every 21 days | Drug | Rucaparib and Pembrolizumab Maintenance |
| CarboplatinAUC 5 IV every 21 days | Drug | Rucaparib and Pembrolizumab Maintenance |
| Rucaparib600mg PO, BID days 1-21 of each 21 day cycle | Drug | Rucaparib and Pembrolizumab Maintenance |
Primary outcome
Median Duration of Time From Start of Treatment to Time of Progression
Time frame: Up to 5 years
The primary endpoint is median progression free survival (PFS) which is defined as the median duration of time from the start of treatment to progression. Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.
2 secondary outcomes
Median Duration of Time From the Start of Treatment Until Death
Time frame: Up to 5 years
Response Rate
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- 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.
Angel Qin, MD principal investigator
University of Michigan Rogel Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab, Pemetrexed and Carboplatin in people with Stage IV Non-small Cell Lung Cancer, run by University of Michigan Rogel Cancer Center at 3 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 10 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: stopped early, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
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 12 Feb 2026). 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?
Median Duration of Time From Start of Treatment to Time of Progression (time frame: Up to 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 12 Feb 2026.