A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

JRCT ID: jRCT2061240062

Registered date:07/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Non-small Cell Lung Cancer
• Date of first enrollment: 30/10/2024
• Target sample size: 132
• Countries of recruitment: Australia,Japan,Belgium,Japan,Brazil,Japan,Canada,Japan,China,Japan,Denmark,Japan,Finland,Japan,France,Japan,Germany,Japan,Hong Kong,Japan,Hungary,Japan,Italy,Japan,Malaysia,Japan,Netherlands,Japan,Norway,Japan,Poland,Japan,South Korea,Japan,Spain,Japan,Sweden,Japan
• Study type: Interventional

Intervention(s)

Arm 1: Dato-DXd in Combination With Rilvegostomig
Participants in the Dato-DXd in combination with rilvegostomig group will receive 6 mg/kg
Dato-DXd plus 750 mg rilvegostomig as IV infusions q3w of D1 of every 21-day cycle for
4 cycles followed by 750 mg rilvegostomig monotherapy as an IV infusion q3w, for up to
12 months/18 cycles in total (whichever is earlier).

Arm 2: Rilvegostomig Monotherapy
Participants in the rilvegostomig monotherapy group will receive rilvegostomig 750 mg as an
IV infusion q3w on D1 of every 21-day cycle for up to 12 months/18 cycles in total
(whichever is earlier).

Arm 3: SoC: Observation Only or UFT
Participants in the SoC group will be observed or recieved UFT (tegafur 250 mg/m2/day, equivalent to tegafur 300 to 600 mg/day), BID or TID, for up to 2 years.

Outcome(s)

Primary Outcome

- 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 SoC [Time Frame: From date of randomisation up to approximately 10 years.]
The 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 and complete recovery after surgery

6. Adequate bone marrow reserve and organ function

Exclude 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

8. History of active primary immunodeficiency

9. Clinically significant corneal disease

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT06564844