A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)

NCT07098338
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
278
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Lead sponsor
AstraZeneca
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Start date
2025-08-07
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Number of sites
83
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Summary
This is a Phase II, multi-center, open-label platform study evaluating novel combination treatment options in participants with locally advanced or metastatic NSCLC. The study will consist of several sub-studies, each evaluating the safety, tolerability, and preliminary antitumour activity of various treatment combinations. This study will be conducted in approximately 80 centers globally across 10 countries.
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Acronym
LIBRA
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Short title
A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
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Official title
An Open-Label, Multi-Drug, Multi-Centre, Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumour Activity of Novel Combinations in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (LIBRA)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2029-04-06
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First posted
2025-08-01
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Registry last updated
2026-07-01
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Primary completion date
2029-04-06
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Start date
2025-08-07
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Participants
278
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Participant count basis
Estimated
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Planned participants
278
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Protocol amendments
2
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Number of sites
83
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07098338
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ClinicalTrials.gov ID
NCT07098338
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with adverse events (AE) and serious adverse events (SAE)

    Timeframe: Through study completion, an average of 3 years

    To assess the safety and tolerability

  2. Objective response rate (ORR)

    Timeframe: Through study completion, an average of 3 years

    ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response) per RECIST 1.1

  1. Best Overall Response(BOR)

    Timeframe: Through study completion, an average of 3 years

    BOR is the best response a participant has had following randomisation/start of dosing, but prior to starting any subsequent cancer therapy and up to and including RECIST progression or the last evaluable assessment in the absence of RECIST progression

  2. Change in Target Lesion Tumor Size

    Timeframe: Through study completion, an average of 3 years

    The best percentage change from baseline in Target Lesion tumour size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST 1.1 assessments

  3. Progression free survival (PFS)

    Timeframe: Through study completion, an average of 3 years

    PFS is defined as the time from the start of treatment until the date of objective disease progression or death (by any cause in the absence of progression) per RECIST 1.1.

  4. Disease Control Rate(DCR) at 12 Weeks

    Timeframe: From Day 1 pre-dose to 12 weeks

    DCR at 12 weeks is defined as the percentage of participants who have a best objective response of confirmed CR or PR or who have SD for at least 11 weeks after start of treatment (to allow for an early assessment within the assessment window).

  5. Duration Of Response (DoR)

    Timeframe: Through study completion, an average of 3 years

    The DoR is defined as the time from the date of first documented objective response (which is subsequently confirmed) until date of first documented disease progression or death (by any cause in the absence of disease progression).

  6. Overall Survival(OS)

    Timeframe: Through study completion, an average of 3 years

    OS is defined as the time from the start of treatment until death due to any cause.

  7. Serum concentration

    Timeframe: Through study completion, an average of 3 years

    To assess the serum concentration of the novel anti-cancer agents in combination.

  8. Maximum plasma drug concentration (Cmax)

    Timeframe: Through study completion, an average of 3 years

    To assess the Cmax of the novel anti-cancer agents in combination.

  9. Immunogenicity of study interventions in participants receiving treatment

    Timeframe: Through study completion, an average of 3 years

    Presence of Anti Drug Antibodies（ADAs) for study interventions in serum/plasma

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Inclusion Criteria for All Sub-studies:

  • Participant must be ≥ 18 years of age at the time of signing the ICF
  • WHO/ECOG performance status of 0 or 1
  • At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.
  • Adequate bone marrow and organ function
  • Life expectancy ≥ 12 weeks
  • Provision of acceptable tumour tissue

Specific Inclusion Criteria for Sub-Study 1 and Sub-Study 2:

  • Histologically or cytologically documented advanced or metastatic NSCLC
  • PD-L1 TC ≥ 1% (TC≥ 50% for sub-study 1, 1-49% for sub-study 2)
  • Absence of sensitizing EGFR mutations or ALK rearrangements. No known other Actionable Genomic Alterations(AGAs)

Specific Inclusion Criteria for Sub-Study 3:

  • Histologically or cytologically documented advanced or metastatic non-squamous NSCLC
  • Documented positive AGA and had progressed on prior targeted therapy

Exclusion Criteria for All Sub-studies:

  • As judged by the investigator, any severe or uncontrolled systemic diseases, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol
  • Active or prior documented autoimmune or inflammatory disorders
  • Persistent toxicities (CTCAE Grade ≥ 2) (NCI CTCAE v5.0) caused by previous anti cancer therapy, excluding alopecia.
  • Spinal cord compression or leptomeningeal carcinomatosis for sub-study 1 and sub-study 2. Unstable spinal cord compression for sub-study 3
  • Unstable brain metastases
  • History of another primary malignancy.
  • Active infection, including TB and infections with HIV, HBV (verified by known positive HBsAg result), HCV.
  • Uncontrolled or significant cardiac disease
  • Receipt of prior systemic chemotherapy/chemoradiation/immunotherapy for advanced NSCLC for sub-study 1 and sub-study 2.
  • Prior exposure to immune-mediated therapy
  • History of uncontrolled hypertension, and active bleeding diseases, and high risks of bleeding and disorders of coagulation
  • Any concurrent anti-cancer treatment.
  • Receipt of live, attenuated vaccine within 30 days prior to the first dose of study intervention.
Sources for eligibility
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  • Research SiteSanta Monica, United StatesRecruiting
  • Research SiteSanta Rosa, United StatesNot yet recruiting
  • Research SiteAtlanta, United StatesRecruiting
  • Research SiteBaltimore, United StatesNot yet recruiting
  • Research SiteHouston, United StatesNot yet recruiting
  • Research SiteFairfax, United StatesRecruiting
  • Research SiteHeidelberg, AustraliaNot yet recruiting
  • Research SiteNedlands, AustraliaNot yet recruiting
  • Research SiteWoodville, AustraliaNot yet recruiting
  • Research SiteToronto, CanadaNot yet recruiting
  • Research SiteChangsha, ChinaRecruiting
  • Research SiteChengdu, ChinaRecruiting
  • Research SiteDeyang, ChinaRecruiting
  • Research SiteDongguan, ChinaRecruiting
  • Research SiteFuzhou, ChinaWithdrawn
  • Research SiteGuangzhou, ChinaRecruiting
  • Research SiteGuangzhou, ChinaRecruiting
  • Research SiteHangzhou, ChinaRecruiting
  • Research SiteHefei, ChinaRecruiting
  • Research SiteLinyi, ChinaRecruiting
  • Research SiteMianyang, ChinaRecruiting
  • Research SiteNanchang, ChinaRecruiting
  • Research SiteNanchang, ChinaRecruiting
  • Research SiteShantou, ChinaRecruiting
  • Research SiteShenyang, ChinaRecruiting

And 58 more, listed on the interactive page.

Sources for sites
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Related records

Drugs (3)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (3)