Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab

NCT05568212 | Recruiting Phase 2

• 1 other identifier: CONDOR
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, non-comparative, phase II study investigating whether: 1) the addition of durvalumab to investigator's choice second line chemotherapy prolongs survival versus investigator's choice second line chemotherapy in NSCLC patients with locally advanced disease progressing on durvalumab given after concomitant chemoradiotherapy; 2) whether the addition of olaparib to durvalumab improves survival over durvalumab alone after induction chemoimmunotherapy in patients relapsing after completing durvalumab maintenance therapy for stage III disease. After evaluation of inclusion and exclusion criteria and after consent form signature, all eligible patients progressing during durvalumab therapy will be in the Part A of the trial randomized to in a 1:1 ratio to investigator's choice single-agent chemotherapy plus durvalumab (Arm A: experimental arm) or to investigator's choice single-agent chemotherapy (Arm B: standard arm). In the clinical trial's Part B, patients progressing after completion of durvalumab therapy will be further randomized in a 1:1.7 ratio to investigator's choice platinum doublet chemotherapy plus durvalumab for 4 cycles followed by maintenance durvalumab plus olaparib (Arm C: experimental arm) or to investigator's choice platinum doublet chemotherapy plus durvalumab for 4 cycles followed by durvalumab (Arm D: experimental arm). Therapy will be continued up to disease progression, toxicity or patient refusal.

Conditions

Non-small-cell Lung Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall Survival (OS) rate at 12 months in patients treated in arm A versus B and in patients treated in arm C versus arm D.

  12 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  12 months

• Objective response rate (ORR)

  Tumor assessment will be performed every 6 weeks for the first 24 weeks and then every 12 weeks until confirmed objective disease progression/death (whichever comes first) assessed up to 30 months.

• Safety and Incidence of AEs

  39 months

• Progression-free survival (PFS) and Overall survival (OS)

  12 months

Study Arms (4)

ARM A (experimental arm)

EXPERIMENTAL

Investigator's choice single-agent chemotherapy plus durvalumab 1500 mg every 3 weeks.

Drug: Durvalumab; Drug: Single-agent chemotherapy

ARM B (standard arm)

EXPERIMENTAL

Investigator's choice single-agent chemotherapy.

Drug: Single-agent chemotherapy

ARM C

EXPERIMENTAL

Investigator's choice platinum doublet chemotherapy plus durvalumab 1500 mg every 3 weeks for 4 cycles followed by maintenance durvalumab 1500 mg every 3 weeks plus olaparib 300 mg twice daily.pp

Drug: Durvalumab; Drug: Olaparib tablet; Drug: Platinum doublet chemotherapy

ARM D (experimental arm)

EXPERIMENTAL

Investigator's choice platinum doublet chemotherapy plus durvalumab 1500 mg every 3 weeks for 4 cycles followed by maintenance durvalumab 1500 mg every 3 weeks

Drug: Durvalumab; Drug: Platinum doublet chemotherapy

Interventions

Durvalumab DRUG

Durvalumab concentrate for solution for infusion will be supplied in glass vials containing 500 mg durvalumab at a concentration of 50 mg/mL

ARM A (experimental arm); ARM C; ARM D (experimental arm)

Olaparib tablet DRUG

Olaparib tablets (100 mg and 150 mg strengths) supplied in high-density polyethylene (HDPE) bottles.

ARM C

Single-agent chemotherapy DRUG

Investigator's choice single-agent chemotherapy regimen

ARM A (experimental arm); ARM B (standard arm)

Platinum doublet chemotherapy DRUG

Investigator's choice platinum doublet chemotherapy

ARM C; ARM D (experimental arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body weight \>30kg
• Recurrent or metastatic NSCLC relapsed during or after completion of chemoradiotherapy with curative intent and maintenance durvalumab for stage III disease. Patients are eligible if they receive at least two cycles of platinum based chemotherapy or radical radiotherapy
• Tumor tissue available for biomarker testing.
• Evidence of disease progression during durvalumab maintenance or at the end of planned treatment. Patients who have interrupted planned durvalumab treatment after at least 6 months for reasons other than toxicity or progression (e.g. patient's choice, logistic reasons, intercurrent acute illnesses) are eligible. Patients progressing during the first three months of Durvalumab are not eligible
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
• Age \>18 years at time of study entry
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Life expectancy of at least 16 weeks
• Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below::
• Haemoglobin ≥10.0 g/dL with no blood transfusion in the past 28 days
• Absolute neutrophil count (ANC) ≥1.5 × 109 /L
• Platelet count ≥100 × 109/L
• Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
• AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN

You may not qualify if:

• No evidence of disease progression
• Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment
• Patients not pretreated with durvalumab with curative intent
• Patients treated with non-radical radiotherapy or with non conventional radiotherapy
• More than 4 cycles of platinum-based chemotherapy
• Rapid progressors. Progressors within first 3 month of treatment will be excluded from this trial
• Any clinical reason that makes the patient ineligible to receive any investigator's choice single-agent chemotherapy regimen (for patients enrolled in cohorts A and B)
• Any clinical reason that makes the patient ineligible to receive any investigator's choice platinum-based doublet chemotherapy regimen (for patients enrolled in cohorts C and D)
• Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
• Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML.
• Disease progression within the first three months of Durvalumab therapy
• Tumor tissue not available
• Evidence of EGFR mutations or ALK or ROS1 rearrangements
• Performance status \>1 (ECOG)
• Brain metastases are allowed if asymptomatic and pretreated. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.

Sponsors & Collaborators

• Fondazione Ricerca Traslazionale: lead

Study Sites (1)

Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena

Roma, RM, 00144, Italy

RECRUITING

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Related Links

• Related Info

MeSH Terms

Interventions

durvalumab; olaparib

Study Officials

• Federico Cappuzzo, MD

  Istituto Nazionale Tumori Regina Elena

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Cappuzzo, MD

CONTACT

06.5266.5698; federico.cappuzzo@ifo.it

Lorenza Landi, MD

CONTACT

3397728272; lorenza.landi@ifo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the group of individuals progressing during durvalumab theray, patients will be randomized to the experimental arm (durvalumab+chemotherapy) or to the standard arm (chemotherapy alone). The standard arm will act as a calibration arm. In the second groups patients will be randomized to the experimental arm durvalumab+chemotherapy followed by maintenance durvalumab+olaparib or to the other experimental arm durvalumab+chemotherapy followed by maintenance durvalumab.

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: October 5, 2022
• Study Start: May 2, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

IT (1)