Lung Cancer - Non Small Cell SquamousPhase 2NCT07353957
Study to Investigate Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Petosemtamab + Pembrolizumab in people with Lung Cancer - Non Small Cell Squamous and Lung Cancer - Non Small Cell Non-Squamous, run by Genmab at 24 sites in 7 countries.
Trial summary
The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer - Non Small Cell Squamous, Lung Cancer - Non Small Cell Non-Squamous
- What is being tested?
- Petosemtamab + Pembrolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 24 sitesin 7 countries
- Study dates
- 27 Mar 2026to 27 Feb 2031
- Phase
- Phase 2
- 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
- Able to provide written informed consent and is willing and able to comply with all study procedures and contraception requirements
- Age ≥ 18 years at the signing of ICF
- At least 1 measurable lesion as defined by RECIST 1.1
- ECOG performance status of 0 or 1
- Life expectancy ≥ 12 weeks, in the opinion of the Investigator
- Adequate hematologic function
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- Creatinine clearance ≥ 60 mL/min calculated according to the Cockroft and Gault formula
- Adequate liver function
- Serum albumin ≥ 3 g/dL
- Serum magnesium and corrected calcium, Grade ≤ 1 alteration
- Participants of childbearing potential must agree to use highly effective contraception methods for the duration of study participation
- Histologically confirmed metastatic (Stage IV) sqNSCLC with PD-L1 TPS ≥ 50%
- No prior systemic treatment for metastatic disease
- Testing is required per local SOC and availability of testing to document absence of actionable genomic tumor aberrations
- Histologically confirmed metastatic (Stage IV) non-squamous NSCLC with PD-L1 TPS ≥ 50%
Who cannot join
- Has untreated CNS metastases and/or carcinomatous meningitis
- Participation in an interventional clinical study with any investigational drug within 4 weeks prior to the first dose of study treatment OR participation in any clinical study with petosemtamab at any time prior to the first dose of study treatment, regardless of whether petosemtamab was received
- Participants who received prior treatment with a PD-(L)1 inhibitor
- Participants who have received prior systemic chemotherapy, targeted or biological antineoplastic therapy for metastatic NSCLC
- Any systemic anticancer therapy within 4 weeks prior to the first dose of study treatment
- Major surgery or radiotherapy within 3 weeks prior to the first dose of study treatment. Participants who received prior radiotherapy to ≥ 25% of bone marrow are not eligible, regardless of when it was received.
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- Persistent Grade > 1 clinically significant toxicities related to prior antineoplastic therapies using NCI-CTCAE v5.0
- History of hypersensitivity reaction to any of the excipients of petosemtamab or pembrolizumab
- Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association criteria or serious cardiac arrhythmia requiring treatment (except atrial fibrillation, paroxysmal supraventricular tachycardia); or history of myocardial infarction within 6 months prior to the first dose of study treatment
- History of prior malignancies within the last 5 years, with the exception of excised local cancer
- Current dyspnea at rest of any origin or other diseases requiring continuous oxygen therapy, including participants with a history of ILD (eg, pneumonitis or pulmonary fibrosis) or evidence of ILD on baseline chest CT scan
- Current serious illness or medical condition, including but not limited to uncontrolled active infection and clinically significant pulmonary, metabolic, or psychiatric disorders
- Known infectious disease
- Participants who are pregnant or breastfeeding.
Trial locations and contacts
24 sites in 7 countries.
24 sites in 7 countries
United States6 sites
Virginia Site 2
Blacksburg, Virginia, 24060
Tennessee Site 2
Chattanooga, Tennessee, 37403
Virginia Site 1
Fairfax, Virginia, 22031
Memorial Sloan Kettering Cancer Center
Long Island City, New York, 11101
Tennessee Site 1
Nashville, Tennessee, 37209
Florida Cancer Specialists - North
St. Petersburg, Florida, 33701-4553
Spain6 sites
START - Rioja
Logroño, 26006
Hospital Quironsalud Malaga
Málaga, 29004
HC Hospitales SL
Marbella, 29660
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008
Hospital Universitario de Navarra
Pamplona, 31008
Hospital Alvaro Cunqueiro
Vigo, 36312
France4 sites
CHU Brest Hopital la Cavale Blanche
Brest, 29609
Centre Hospitalier Intercommunal de Creteil (CHIC)
Créteil, 94000
ICM - Montpellier Cancer Institute
Montpellier, 34298
Hopital Nord Laennec
Nantes, 44093
South Korea4 sites
Chungbuk National University Hospital
Cheongju-si, 28645
Kyungpook National University Chilgok Hospital
Daegu, 41404
Severance Hospital - Yonsei University Health System
Seoul, 3722
The Catholic University of Korea, St. Vincents Hospital
Suwon, 16247
Australia2 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Australia Site 1
Frankston, Victoria, 3199
Italy1 site
Universita degli Studi di Firenze - Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
About this study
Official title: A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer in Combination With Pembrolizumab as First-Line Treatment
The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.
- Being tested
- Petosemtamab + Pembrolizumab
- Keywords
- squamous, lung cancer, non-squamous lung cancer, petosemtamab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Petosemtamab + PembrolizumabCombination product
Petosemtamab + Pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| First line squamous non-small cell lung cancer patients | Experimental | Not described Receives: Combination Product: Petosemtamab + Pembrolizumab |
| First line non-squamous non-small cell lung cancer patients | Experimental | Not described Receives: Combination Product: Petosemtamab + Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate per investigator assessment
ORR was defined as the proportion of participants who had a complete response (CR) or partial response (PR) per RECIST v1.1.
Measured: Up to 4.5 years
Secondary outcomes (8)
Duration of response per Investigator assessment
For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer.
Measured: Up to 4.5 years
Disease control rate as per investigator assessment
DCR is defined as the proportion of participants with CR or PR or stable disease (SD) per RECIST 1.1.
Measured: Up to 4.5 years
Clinical Benefit Rate as per investigator assessment
CBR was defined as the proportion of participants with a CR or PR, or SD lasting ≥24 weeks per RECIST v1.1
Measured: Up to 4.5 years
Progression free survival as per investigator assessment
PFS was defined as the time from first dose to the first documented disease progression per RECIST v1.1 or death due to any cause.
Measured: Up to 4.5 years
Overall survival
OS was defined as the time from first dose to death due to any cause.
Measured: Up to 4.5 years
Number of participants who experienced on treatment adverse events
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Severity of AEs will be graded according to the NCI CTCAE version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening and Grade 5: death related to adverse event.
Measured: Up to 4.5 years
Concentrations of petosemtamab predose and at end of infusion
Predose and end of infusion plasma concentrations as measured from all individual plasma concentrations.
Measured: Up to 6-12 months
Incidence and serum titers of anti-drug antibodies (ADAs) against petosemtamab
The frequency and proportion of participants developing anti-drug antibodies.
Measured: Up to 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start27 Mar 2026
- Primary completion31 May 2028 (estimated)
- Study completion27 Feb 2031 (estimated)
Why it stopped: This study-level decision was based on the evolving treatment landscape and strategic portfolio considerations and is not related to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer - Non Small Cell SquamousStudies of the same condition, open and under way.
- More trials run by GenmabThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353957
- Sponsor's protocol ID
- MCLA-158-CL04
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer in Combination With Pembrolizumab as First-Line Treatment
- ClinicalTrials.gov ID
- NCT07353957
- Acronym / sponsor ID
- MCLA-158-CL04
- Keywords
- squamous, lung cancer, non-squamous lung cancer, petosemtamab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study-level decision was based on the evolving treatment landscape and strategic portfolio considerations and is not related to any safety concern.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 27 Feb 2031 (estimated)
- First posted
- 21 Jan 2026 (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 study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First line squamous non-small cell lung cancer patients | Experimental | Combination Product: Petosemtamab + Pembrolizumab |
| First line non-squamous non-small cell lung cancer patients | Experimental | Combination Product: Petosemtamab + Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Able to provide written informed consent and is willing and able to comply with all study procedures and contraception requirements
- Age ≥ 18 years at the signing of ICF
- At least 1 measurable lesion as defined by RECIST 1.1
- ECOG performance status of 0 or 1
- Life expectancy ≥ 12 weeks, in the opinion of the Investigator
Key exclusion criteria (14 listed)
- Has untreated CNS metastases and/or carcinomatous meningitis
- Participation in an interventional clinical study with any investigational drug within 4 weeks prior to the first dose of study treatment OR participation in any clinical study with petosemtamab at any time prior to the first dose of study treatment, regardless of whether petosemtamab was received
- Participants who received prior treatment with a PD-(L)1 inhibitor
- Participants who have received prior systemic chemotherapy, targeted or biological antineoplastic therapy for metastatic NSCLC
- Any systemic anticancer therapy within 4 weeks prior to the first dose of study treatment
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 |
|---|---|---|
| Petosemtamab + PembrolizumabPetosemtamab + Pembrolizumab | Combination product | First line non-squamous non-small cell lung cancer patients, First line squamous non-small cell lung cancer patients |
Primary outcome
Objective response rate per investigator assessment
Time frame: Up to 4.5 years
ORR was defined as the proportion of participants who had a complete response (CR) or partial response (PR) per RECIST v1.1.
8 secondary outcomes
Duration of response per Investigator assessment
Time frame: Up to 4.5 years
Disease control rate as per investigator assessment
Time frame: Up to 4.5 years
Clinical Benefit Rate as per investigator assessment
Time frame: Up to 4.5 years
Progression free survival as per investigator assessment
Time frame: Up to 4.5 years
Overall survival
Time frame: Up to 4.5 years
Number of participants who experienced on treatment adverse events
Time frame: Up to 4.5 years
Concentrations of petosemtamab predose and at end of infusion
Time frame: Up to 6-12 months
Incidence and serum titers of anti-drug antibodies (ADAs) against petosemtamab
Time frame: Up to 6-12 months
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Study Official study director
Genmab
24 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Petosemtamab + Pembrolizumab in people with Lung Cancer - Non Small Cell Squamous and Lung Cancer - Non Small Cell Non-Squamous, run by Genmab at 24 sites in 7 countries.
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 15 inclusion and 14 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Spain, France, South Korea, Australia and 2 more countries. 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?
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?
Objective response rate per investigator assessment (time frame: Up to 4.5 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 2 Nov 2026.