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A Platform Study in Non-Small Cell Lung Cancer (NSCLC)

ConditionAdvanced or Metastatic Non-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Presence of small cell and neuroendocrine histology components.

Any severe or uncontrolled systemic diseases, including uncontrolled hypertension, and active bleeding diseases, ongoing or active known infection; interstitial lung disease/pneumonitis (of any grade); unstable and/or symptomatic venous thromboembolism, 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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Rilvegostomig

    Drug

    Rilvegostomig will be administered as an intravenous (IV) infusion.

  • Cisplatin

    Drug

    Cisplatin will be administered as SoC as an IV infusion.

  • Carboplatin

    Drug

    Carboplatin will be administered as SoC as an IV infusion.

  • Pemetrexed

    Drug

    Pemetrexed will be administered as SoC as an IV infusion.

  • Paclitaxel

    Drug

    Paclitaxel will be administered as SoC as an IV infusion.

  • Nab-paclitaxel

    Drug

    Nab-paclitaxel will be administered as SoC as an IV infusion.

  • Ramucirumab

    Drug

    Ramucirumab will be administered as an IV infusion.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Sub study 2 Part A: Safety run-inExperimental treatment 7 interventions
Group B: Sub study 2 Part B: Dose expansionExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Part A and Part B: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.

Time frame
Approximately 46 months
2

Part A: Number of partcipants with dose limiting toxicity (DLT)

To assess the safety and tolerability and determine RP2D of the combination of novel anti-cancer agents.

Time frame
Approximately 46 months
3

Part B: Objective response (OR)

The OR is defined as a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR).

Time frame
Approximately 46 months

Secondary outcomes

1

Part A: Objective response (OR)

The OR is defined as a BOR of confirmed CR or confirmed PR.

Time frame
Approximately 46 months
2

Part A and Part B: Duration of response (DOR)

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).

Time frame
Approximately 46 months
3

Part A and Part B: Time to response (TTR)

Time to response is defined as the time from the start of treatment until the date of first documented response.

Time frame
Approximately 46 months
4

Part A and Part B: Disease control (DC)

Disease control is defined as if a participant has a best overall response of confirmed CR or confirmed PR or who have stable disease (SD) for at least 7 weeks after start of treatment.

Time frame
Approximately 46 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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