A Platform Study in Non-Small Cell Lung Cancer (NSCLC) (ALTAIR)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of this study is to assess the safety and efficacy of multiple study interventions including novel-novel combinations or novel agents in combination with standard therapy for the treatment of metastatic NSCLC.
Full description
This is a multicentre, open-label study to evaluate the safety and efficacy of various combinations of study interventions in participants with advanced or metastatic NSCLC (mNSCLC).
The study will include sub-studies (sub-study 1 and sub-study 2) and each sub-study focused on a specific treatment may include 2 parts -
- Part A consisting of one of more safety run-in cohorts to evaluate 2 or more dose levels to identify the recommended Phase 2 dose (RP2D) unless RP2D has been established then Part A will not be required; and
- Part B consisting of one or more expansion cohorts.
Sub-study 1 will investigate the safety, tolerability, and anti-tumour activity of combination of rilvegostomig and AB248.
Sub-study 2 will evaluate the safety, tolerability, and anti-tumour activity of rilvegostomig and standard of care (SoC) platinum-based chemotherapy. Safety run-in (Part A) will not be conducted in sub-study 2.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria (both sub study 1 and sub study 2):
- Participants with confirmed squamous or non-squamous NSCLC with a current Stage IV mNSCLC.
- Provision of acceptable archival tumour tissue (or fresh tumour tissue biopsy if archival tumour tissue is not available and if clinically feasible) is mandatory at screening.
- Measurable disease as defined by at least one lesion that can be accurately measured at baseline as ≥ 10 mm at the longest diameter.
- Minimum life expectancy of 12 weeks in the opinion of the investigator.
- Adequate organ and marrow function.
- Contraceptive use by male or female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Adequate organ and marrow function and minimum body weight of 30 Kg.
- PD-L1 tumour proportion score (TPS) ≥ 1% (per local report).
Exclusion Criteria (both sub study 1 and sub study 2):
- Participants with epidermal growth factor receptor mutations, anaplastic lymphoma receptor fusions or any other known genomic alteration for which targeted therapy is approved in the first line per local standard of care.
- Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; serious chronic gastrointestinal conditions associated with diarrhoea, active non-infectious skin disease or substance abuse.
- Has had a prior stem cell, bone marrow, allogenic tissue, or solid organ transplant.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- History of clinically significant arrhythmia, cardiomyopathy of any aetiology or symptomatic congestive heart failure.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention or presence of small cell and neuroendocrine histology components.
- Unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy, spinal cord compression or symptomatic brain metastases.
- Any prior systemic therapy received for advanced or mNSCLC or treatment with any other anti-cancer agents or immunosuppressive medication.
- Palliative radiotherapy with a limited field of radiation within 2 weeks or with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks, prior to the first dose of study intervention.
- Active tuberculosis infection.
- Any prior exposure to an anti-T-cell immunoreceptor with Ig and Immunoreceptor Tyrosine-based Inhibition Motif (ITIM) domains (TIGIT) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
- Any prior systemic treatment with an immune-oncology agent, including but not limited to anti-PD-1, anti-PD-L1, anti-Cytotoxic T-lymphocyte Associated Antigen 4 (CTLA-4).
Exclusion Criteria for Sub study 1:
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has either a known history of Hepatitis B virus or has active Hepatitis C virus.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis/interstitial lung disease.
Exclusion Criteria for Sub study 2:
- Known active hepatitis A, chronic or active hepatitis B, or chronic or active hepatitis C infection.
- Known HIV infection that is not well controlled.
Trial design
Primary purpose
Allocation
Interventional model
Masking
143 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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