Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

Conditions

• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 95 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  Participants will receive Durvalumab via intravenous route.
• Oleclumab — DRUG
  Participants will receive Oleclumab via intravenous route.
• Monalizumab — DRUG
  Participants will receive Monalizumab via intravenous route.
• Dato-DXd — DRUG
  Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route.
• AZD0171 — DRUG
  Participants will receive AZD0171 via intravenous route.
• Carboplatin — DRUG
  Carboplatin as chemotherapy
• Cisplatin — DRUG
  Cisplatin as chemotherapy
• Pemetrexed/Cisplatin — DRUG
  Pemetrexed/Cisplatin as chemotherapy
• Pemetrexed/Carboplatin — DRUG
  Pemetrexed/Carboplatin as chemotherapy
• Carboplatin/Paclitaxel — DRUG
  Carboplatin/Paclitaxel, as chemotherapy
• Volrustomig — DRUG
  Participants will receive Volrustomig via intravenous route.
• Rilvegostomig — DRUG
  Participants will receive Rilvegostomig via intravenous route.

Study Details

The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with resectable, early-stage non-small cell lung cancer.

Key Dates

Start date

Apr 14, 2022

Status verified

May 2026

Primary completion

May 28, 2030

Completion

May 28, 2030

Study Design

Enrollment

630 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)
  Participants will receive Durvalumab + Oleclumab + CTX as neoadjuvant treatment and Durvalumab + Oleclumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
• Experimental: Arm 2: Monalizumab + Durvalumab + CTX
  Participants will receive Durvalumab + Monalizumab + CTX as neoadjuvant treatment and Durvalumab + Monalizumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
• Experimental: Arm 3: Volrustomig (Dose Exploration) + CTX
  Participants will receive Volrustomig + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
• Experimental: Arm 4: Dato-DXd + durvalumab + single agent platinum
  Participants will receive Dato-DXd + durvalumab + single agent platinum as neoadjuvant treatment and durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin
• Experimental: Arm 5: AZD0171 + durvalumab + CTX
  Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
• Experimental: Arm 6: Rilvegostomig + CTX
  Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin
• Experimental: Arm 7: Dato-DXd + Rilvegostomig + single agent platinum
  Participants will receive Dato-DXd + Rilvegostomig + single agent platinum as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin

Primary Outcome Measure

Number of participants with pathological complete response (pCR) [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]

Central Contacts

• AstraZeneca Clinical Study Information Center
  1-877-240-9479
  [email protected]
• AstraZeneca Lung Cancer Study Locator Service
  1-884-432-3892
  [email protected]

Locations (25)

Find similar trials in Little Rock, AR

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