Lung Cancer - Non Small Cell Non-Squamous, Lung Cancer - Non Small Cell Squamous
Conditions
Keywords
squamous, lung cancer, non-squamous lung cancer, petosemtamab
Brief 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.
Interventions
COMBINATION_PRODUCTPetosemtamab + Pembrolizumab
Petosemtamab + Pembrolizumab
Sponsors
Merus B.V.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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%
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate per investigator assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response per Investigator assessment | Up to 4.5 years | 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. |
| Disease control rate as per investigator assessment | Up to 4.5 years | DCR is defined as the proportion of participants with CR or PR or stable disease (SD) per RECIST 1.1. |
| Clinical Benefit Rate as per investigator assessment | Up to 4.5 years | CBR was defined as the proportion of participants with a CR or PR, or SD lasting ≥24 weeks per RECIST v1.1 |
| Progression free survival as per investigator assessment | Up to 4.5 years | 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. |
| Overall survival | Up to 4.5 years | OS was defined as the time from first dose to death due to any cause. |
| Number of participants who experienced on treatment adverse events | Up to 4.5 years | 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. |
| Concentrations of petosemtamab predose and at end of infusion | Up to 6-12 months | Predose and end of infusion plasma concentrations as measured from all individual plasma concentrations. |
| Incidence and serum titers of anti-drug antibodies (ADAs) against petosemtamab | Up to 6-12 months | The frequency and proportion of participants developing anti-drug antibodies. |
Countries
Australia, France, Italy, Netherlands, South Korea, Spain, United States
Outcome results
None listed