NSCLC Stage IVPhase 2NCT04166487

Plasma-Adapted First-Line Pembro In NSCLC

A Phase 2 study testing Pembrolizumab, PEMETREXED and CARBOPLATIN in people with NSCLC Stage IV and Metastatic Non-Small Cell Lung Cancer, run by Julia K. Rotow, MD at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This research study is studying to see if a blood test, collected at different times during the treatment of metastatic non-small lung cancer, can be used to detect early response in patients being treated with pembrolizumab and use that information to determine whether patients should continue treatment with… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC Stage IV, Metastatic 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: 40 participants
Where: 5 sitesUnited States
Study dates: 13 Jan 2020to 1 Dec 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

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

Participants must have histologically or cytologically confirmed stage IV NSCLC (AJCC 8th edition).
Participants must have evaluable disease on imaging per RECIST (measurable disease is not required).
No prior treatment with a systemic anti-cancer therapy of any kind for the treatment of stage IV NSCLC. Prior definitive chemoradiation for locally advanced disease, or prior adjuvant or neoadjuvant therapy for early stage disease is permitted if completed ≥6 months prior to initiating study treatment.
Age ≥18 years.
ECOG performance status 0-2 (see Appendix A)
Candidate for combination chemoimmunotherapy per physician assessment.

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Participants must have normal organ and marrow function as defined below:
-- absolute neutrophil count ≥1000/mcL
platelets ≥100,000/mcL
total bilirubin <1.3 mg/dL
creatinine <1.6 mg/dL
PD-L1 tumor proportion score (TPS) ≥1%, as determined by a CLIA-laboratory.
The effects of pembrolizumab on the developing human fetus are unknown. For this reason and because immune checkpoint blockade agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of pembrolizumab administration.
-- NOTE: a pregnancy test will be required at screening for women of childbearing potential.
Ability to understand and the willingness to sign a written informed consent document.
Inclusion Criteria for Treatment Continuation at Cycle 3 -- Completion of repeat plasma NGS (InVision) on study, with plasma response defined as ≥50% reduction in plasma ctDNA max AF between C1D1 and C2D1 for patients with high shed [≥0.5% max AF] at C1D1, or continued low shed [<0.5% max AF] for patients with low shed at C1D1.
Completion of restaging scans on study, with response determined by central review per RECIST 1.1 criteria
For participants continuing pembrolizumab alone:
Response of Partial Response or Complete Response at Cycle 3 imaging assessment (as determined by TIMC).
OR --- Response of Stable Disease at Cycle 3 imaging assessment (as determined by TIMC) AND plasma response.
OR
Response of Progressive Disease at Cycle 3 imaging assessment (as determined by TIMC) without worsening cancer symptoms (as determined by the treating investigator) AND plasma response.
-- For participants continuing pembrolizumab + doublet chemotherapy:
Response of Stable Disease at Cycle 3 imaging assessment (as determined by TIMC) AND no plasma response.
OR --- Response of Progressive Disease at Cycle 3 imaging assessment (as determined by TIMC) without worsening cancer symptoms (as determined by the treating investigator) AND no plasma response.
NOTE: Patients with a response of Progressive Disease at Cycle 3 imaging assessment (as determined by TIMC) with worsening cancer symptoms (as determined by the treating investigator) must come off treatment.

Who cannot join

Participants with known sensitizing alterations in EGFR, ALK, ROS1 or BRAF.
Participants who have had chemotherapy or radiotherapy within 1 week prior to entering the study.
Participants who are receiving any other investigational agents.
Participants with uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression. Patients with asymptomatic untreated brain metastases are eligible. Patients with treated CNS disease are eligible if stable disease is clinically confirmed ≥2 weeks after definitive CNS therapy (radiation or surgery), and the patient is not receiving systemic steroids ≥10mg of prednisone equivalent at the time of enrollment.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in study.
Ongoing or active autoimmune disease requiring systemic steroids of ≥10mg of prednisone equivalent or other systemic immunomodulatory agents at the time of enrollment. Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as psoriasis, vitiligo, and alopecia) not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are allowed.

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Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because pembrolizumab is a Pregnancy Category D agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab, breastfeeding should be discontinued if the mother is treated with pembrolizumab. These potential risks may also apply to other agents used in this study.
Participants with a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are excluded from this study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Dana-Farber at Steward St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in clinical affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190

Other trials in United States

About this study

Official title: Pilot Study of Serial Plasma Genotyping to Guide the Adaptive Treatment of Advanced NSCLC Receiving First-line Pembrolizumab

The names of the study drugs involved in this study are:

Pembrolizumab
Platinum doublet chemotherapy, which may include the following:
Carboplatin and pemetrexed
Carboplatin and paclitaxel

The name of the blood test:

InVision (Inivata, Ltd.)

Read the detailed description

This is an open label, single institution, prospective pilot study.

The purpose of this research study is to determine if a blood test, collected at different times during treatment, can be used to detect early response in patients being treated with pembrolizumab for lung cancer and use that information to determine whether patients should continue treatment with pembrolizumab or switch treatment to pembrolizumab in combination with chemotherapy.

-The research study procedures include screening for eligibility and study treatment including evaluations approximately every 3 weeks.

The names of the study drugs involved in this study are:

Pembrolizumab
Platinum doublet chemotherapy, which may include the following:
Carboplatin and pemetrexed
Carboplatin and paclitaxel

The name of the blood test:

InVision- Inivata
This blood test that will help study how participants respond to the study treatment. ---
Blood will be collected for this test at a few time points, both before and after participants receive treatment on study.
Participants will be on the research study for up to 12 months.
It is expected that about 40 people will take part in this research study.

Conditions: NSCLC Stage IV, Metastatic Non-Small Cell Lung Cancer
Being tested: Pembrolizumab, PEMETREXED, CARBOPLATIN, PACLITAXEL, InVision
Keywords: NSCLC Stage IV, Metastatic Non-Small Cell Lung Cancer
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
Also called Keytruda®
predetermined dose, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
PEMETREXEDDrug
Also called Alimta®
administered per standard practice, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
CARBOPLATINDrug
Also called Paraplatin ®
administered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
PACLITAXELDrug
Also called Taxol®,, Onxal
administered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
InVisionDiagnostic test
Plasma draw for clinical test performed at C1D1 and C2D1; plasma draw for research testing performed at other timepoints per protocol.

Study groups in NCT04166487
Study group	Role	What they receive
Pembrolizumab Cycles 1-2	Experimental	* For the first two cycles, Pembrolizumab will be administered at a predetermined dose every 3 weeks. * InVision plasma draw will take place at Cycle 1 Day 1 and Cycle 2 Day 1, with return of results to the treating oncologist prior to Cycle 3 Day 1. * At Cycle 3, patients will be re-registered per the inclusion criteria into 3 arms; * PEMBROLIZUMAB Alone * PEMBROLIZUMAB + Doublet Chemotherapy Receives: Drug: Pembrolizumab; Diagnostic Test: InVision
Pembrolizumab Alone, Cycle 3+	Experimental	- Following imaging assessment at Cycle 3, participants will continue pembrolizumab alone if the following responses are observed: * Response of Partial Response/Complete Response * Response of Stable Disease with plasma response * Response of Progressive Disease without worsening cancer symptoms AND plasma response Receives: Drug: Pembrolizumab
Pembrolizumab + Doublet Chemotherapy, Cycles 3+	Experimental	* Following imaging assessment at Cycle 3, participants will receive pembrolizumab in combination with platinum doublet chemotherapy if they have a response of stable disease without plasma response, OR no plasma response and response of progressive disease without worsening cancer systems. Platinum doublet should be histology-appropriate and will be given on-label, per treating oncologist. * PEMBROLIZUMAB * Chemotherapy multiple agents systemic * PEMETREXED * CARBOPLATIN * PACLITAXEL Receives: Drug: Pembrolizumab; Drug: PEMETREXED; Drug: CARBOPLATIN; Drug: PACLITAXEL

What is being measured

The primary outcome is the main question the study is designed to answer.

6-month Progression Free Survival rate
Kaplan-Meier method
Measured: 6 Months

Secondary outcomes (4)

Early Plasma Response
Early plasma response is defined as ≥50% reduction in plasma ctDNA max AF between Cycle 1 Day 1 and Cycle 2 Day 1 for patients with high shed [≥0.5% max AF] at Cycle 1 Day 1, or persistent low shed [<0.5% max AF] for patients with low shed at Cycle 1 Day 1.
Measured: 42 Days (each cycle is 21 days)
Progression Free Survival
Kaplan-Meier method will be used to estimate event-time distributions and medians for time-to-event data
Measured: he time from registration to the earlier of progression or death due to any cause or 30 Months
Overall Survival
Kaplan-Meier method will be used to estimate event-time distributions and medians for time-to-event data
Measured: time from registration to death from any cause, and patients who are thought to be alive at the time of final analysis will be censored at the last date of contact or 30 months
Feasibility-adherence to protocol therapy for 4 cycles
Feasibility is defined as a patient's adherence to protocol therapy for 4 cycles
Measured: 84 Days (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 20201 Dec 2026

First posted18 Nov 2019
Study start13 Jan 2020
Primary completion1 Jun 2025
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLC Stage IVStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04166487
Sponsor's protocol ID: 19-523
Status last verified: Jan 2026
First submitted: 13 Nov 2019
Last updated: 22 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study of Serial Plasma Genotyping to Guide the Adaptive Treatment of Advanced NSCLC Receiving First-line Pembrolizumab
ClinicalTrials.gov ID: NCT04166487
Acronym / sponsor ID: 19-523
Conditions: NSCLC Stage IV, Metastatic Non-Small Cell Lung Cancer
Keywords: NSCLC Stage IV, Metastatic Non-Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 40 participants (actual)
Lead sponsor: Julia K. Rotow, MDUniversity, hospital or other
Collaborators: Inivata
Study start: 13 Jan 2020 (actual)
Primary completion: 1 Jun 2025 (actual)
Study completion: 1 Dec 2026 (estimated)
First posted: 18 Nov 2019 (actual)
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 names of the study drugs involved in this study are:

Pembrolizumab
Platinum doublet chemotherapy, which may include the following:
Carboplatin and pemetrexed
Carboplatin and paclitaxel

The name of the blood test:

InVision (Inivata, Ltd.)

Detailed description

This is an open label, single institution, prospective pilot study.

-The research study procedures include screening for eligibility and study treatment including evaluations approximately every 3 weeks.

The names of the study drugs involved in this study are:

Pembrolizumab
Platinum doublet chemotherapy, which may include the following:
Carboplatin and pemetrexed
Carboplatin and paclitaxel

The name of the blood test:

InVision- Inivata
This blood test that will help study how participants respond to the study treatment. ---
Blood will be collected for this test at a few time points, both before and after participants receive treatment on study.
Participants will be on the research study for up to 12 months.
It is expected that about 40 people will take part in this research study.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Pembrolizumab Cycles 1-2	Experimental	Drug: Pembrolizumab, Diagnostic Test: InVision* For the first two cycles, Pembrolizumab will be administered at a predetermined dose every 3 weeks. * InVision plasma draw will take place at Cycle 1 Day 1 and Cycle 2 Day 1, with return of results to the treating oncologist prior to Cycle 3 Day 1. * At Cycle 3, patients will be re-registered per the inclusion criteria into 3 arms; * PEMBROLIZUMAB Alone * PEMBROLIZUMAB + Doublet Chemotherapy
Pembrolizumab Alone, Cycle 3+	Experimental	Drug: Pembrolizumab- Following imaging assessment at Cycle 3, participants will continue pembrolizumab alone if the following responses are observed: * Response of Partial Response/Complete Response * Response of Stable Disease with plasma response * Response of Progressive Disease without worsening cancer symptoms AND plasma response
Pembrolizumab + Doublet Chemotherapy, Cycles 3+	Experimental	Drug: Pembrolizumab, Drug: PEMETREXED, Drug: CARBOPLATIN, Drug: PACLITAXEL* Following imaging assessment at Cycle 3, participants will receive pembrolizumab in combination with platinum doublet chemotherapy if they have a response of stable disease without plasma response, OR no plasma response and response of progressive disease without worsening cancer systems. Platinum doublet should be histology-appropriate and will be given on-label, per treating oncologist. * PEMBROLIZUMAB * Chemotherapy multiple agents systemic * PEMETREXED * CARBOPLATIN * PACLITAXEL

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

Participants must have histologically or cytologically confirmed stage IV NSCLC (AJCC 8th edition).
Participants must have evaluable disease on imaging per RECIST (measurable disease is not required).
No prior treatment with a systemic anti-cancer therapy of any kind for the treatment of stage IV NSCLC. Prior definitive chemoradiation for locally advanced disease, or prior adjuvant or neoadjuvant therapy for early stage disease is permitted if completed ≥6 months prior to initiating study treatment.
Age ≥18 years.
ECOG performance status 0-2 (see Appendix A)

Key exclusion criteria (9 listed)

Participants with known sensitizing alterations in EGFR, ALK, ROS1 or BRAF.
Participants who have had chemotherapy or radiotherapy within 1 week prior to entering the study.
Participants who are receiving any other investigational agents.
Participants with uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression. Patients with asymptomatic untreated brain metastases are eligible. Patients with treated CNS disease are eligible if stable disease is clinically confirmed ≥2 weeks after definitive CNS therapy (radiation or surgery), and the patient is not receiving systemic steroids ≥10mg of prednisone equivalent at the time of enrollment.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab or other agents used in study.

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
PembrolizumabAlso: Keytruda®predetermined dose, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.	Drug	Pembrolizumab + Doublet Chemotherapy, Cycles 3+, Pembrolizumab Alone, Cycle 3+, Pembrolizumab Cycles 1-2
PEMETREXEDAlso: Alimta®administered per standard practice, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.	Drug	Pembrolizumab + Doublet Chemotherapy, Cycles 3+
CARBOPLATINAlso: Paraplatin ®administered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.	Drug	Pembrolizumab + Doublet Chemotherapy, Cycles 3+
PACLITAXELAlso: Taxol®,, Onxaladministered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.	Drug	Pembrolizumab + Doublet Chemotherapy, Cycles 3+
InVisionPlasma draw for clinical test performed at C1D1 and C2D1; plasma draw for research testing performed at other timepoints per protocol.	Diagnostic test	Pembrolizumab Cycles 1-2

Primary outcome

6-month Progression Free Survival rate
Time frame: 6 Months
Kaplan-Meier method

4 secondary outcomes

Early Plasma Response
Time frame: 42 Days (each cycle is 21 days)
Progression Free Survival
Time frame: he time from registration to the earlier of progression or death due to any cause or 30 Months
Overall Survival
Time frame: time from registration to death from any cause, and patients who are thought to be alive at the time of final analysis will be censored at the last date of contact or 30 months
Feasibility-adherence to protocol therapy for 4 cycles
Time frame: 84 Days (each cycle is 21 days)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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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.

Julia K Rotow, MD principal investigator

Dana-Farber Cancer Institute

5 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, PEMETREXED and CARBOPLATIN in people with NSCLC Stage IV and Metastatic Non-Small Cell Lung Cancer, run by Julia K. Rotow, MD at 5 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 26 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

This study is still under way. Results are not available in the source record yet.

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?

6-month Progression Free Survival rate (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04166487.

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 22 Jul 2026.