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A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

PHASE3ACTIVE_NOT_RECRUITING

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Study details:

The primary objective of the study is to assess the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig relative to SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Histologically documented treatment-naive Stage I (T < 4 cm, AJCC 8th ed) adenocarcinoma NSCLC
  2. Complete surgical resection (R0) of the primary NSCLC
  3. Unequivocal no evidence of disease at post-surgical
  4. Pre-surgical ctDNA-positive result (Stage IA or IB) OR presence of at least one high-risk pathological feature (visceral pleural invasion (VPI), lymphovascular invasion (LVI), high-grade histology) (Stage IB only)
  5. ECOG of 0 or 1, life expectancy of > 6 months and complete recovery after surgery
  6. Adequate bone marrow reserve and organ function

Exclusion criteria

  1. Sensitizing EGFR mutation and/or ALK alteration
  2. History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  3. Significant pulmonary function compromise
  4. History of another primary malignancy within 3 years (with exceptions)
  5. Any evidence of severe or uncontrolled systemic diseases, including but not limited to bleeding diseases, active infection and cardiac disease
  6. Active or prior documented autoimmune or inflammatory disorders (with exceptions)
  7. Active infection with tuberculosis, hepatitis B or C virus, hepatitis A, or known HIV infection that is not well controlled
  8. History of active primary immunodeficiency
  9. Clinically significant corneal disease

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE3

trial

Study ID

NCT06564844

Intervention or treatment

DRUG: Datopotamab Deruxtecan

DRUG: Rilvegostomig

DRUG: Carboplatin

DRUG: Cisplatin

DRUG: Etoposide

DRUG: Pemetrexed

DRUG: Vinorelbine

DRUG: UFT

Conditions

  • Non-small Cell Lung Cancer

  • Condition: Non-small Cell Lung Cancer

  • DRUG: Datopotamab Deruxtecan and other drugs

  • Camperdown, Australia and more

  • Sponsor: AstraZeneca

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Research sites nearby

Closest Location:

Research Site

Select from list below to view details:

  • Research Site

    Camperdown, Australia

  • Research Site

    Murdoch, Australia

  • Research Site

    Townsville, Australia

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Who is running the clinical trial?

A

AstraZeneca

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Dato-DXd + rilvegostomig
  • Participants in the Dato-DXd in combination with rilvegostomig group will receive Dato-DXd and rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
Drug: Datopotamab Deruxtecan, Drug: Rilvegostomig
    EXPERIMENTAL: Rilvegostomig
    • Participants in the rilvegostomig monotherapy group will receive rilvegostomig as intravenous (IV) infusion every 3 weeks (Q3W).
    Drug: Rilvegostomig
      ACTIVE_COMPARATOR: Standard of Care (SoC)
      • Patients in SoC group will undergo observation or will receive Investigator's Choice of Chemotherapy (ICC).
      Drug: Carboplatin, Drug: Cisplatin, Drug: Etoposide, Drug: Pemetrexed, Drug: Vinorelbine, Drug: UFT

        What is the study measuring?

        Primary Outcome

        MeasureDescriptionTime Frame
        Disease-Free Survival (DFS) using BICR in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoCThe analysis will include all randomised participants as randomised. All events will be included, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy. The measure of interest is the HR of DFS. Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.From date of randomisation up to approximately 10 years.

        Secondary Outcome

        MeasureDescriptionTime Frame
        Overall Survival (OS) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoCThe analysis will include all randomised participants as randomised. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy. The measure of interest is the HR of OS. Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.From date of randomisation up to approximately 10 years.
        Participant-reported physical function in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoCThe analysis will include all randomised participants as randomised. The physical function will be measured by the PROMIS SF PF 8c. Data from PROMIS SF PF 8c will capture participants' perceived ability to perform specific activities from daily life and will be scored on a 5-point rating scale. The measure of interest will be the between treatment group difference in adjusted mean in physical function scores. Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.Measured at weeks 12, 24 and 48.
        Participant-reported GHS/QoL in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive or having at least one high-risk pathological feature treated with adjuvant Dato-DXd in combination with rilvegostomig relative to SoCThe analysis will include all randomised participants as randomised. The GHS/QoL scores will be measured by the GHS/QoL scale from EORTC IL172. The measure of interest will be the between treatment group difference in adjusted mean in GHS/QoL scores. Descriptive analyses of Dato-DXd in combination with rilvegostomig versus rilvegostomig monotherapy and rilvegostomig monotherapy versus SoC will be performed to assess contribution of components.Measured at weeks 12, 24 and 48.
        Pharmacokinetics (PK)Concentration of Dato-DXd, total anti-TROP2 antibody, and MAAA-1181a (payload deruxtecan) in plasma or serum.Up to 30 or 90 days post-last dose of study intervention.
        Pharmacokinetics (PK)Concentration of rilvegostomig in plasma or serum.Up to 30 or 90 days post-last dose of study intervention.
        Pharmacokinetics (PK)PK parameters (peak and through concentrations).Up to 30 or 90 days post-last dose of study intervention.
        ImmunogenicityPresence of ADAs for Dato-DXd and rilvegostomig (confirmatory results: titres and neutralising antibodies for confirmed positive samples).Up to 30 or 90 days post-last dose of study intervention.
        Are you running this trial?If you're a clinic or sponsor, you can claim this study.
        Claim this trial

        References

        Clinical Trials Gov: A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

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