Chemo-immunotherapy, Hypo-fractionated RT and Maintenance Immunotherapy for Stage III NSCLC.

NCT05128630 | Unknown Phase 2

• 1 other identifier: 20210040686
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this phase 2 study is to evaluate the safety and the efficacy of the combination of induction chemotherapy plus durvalumab followed by reduced-dose hypo-fractionated thoracic RT (concurrent with durvalumab) and durvalumab maintenance for stage 3 unresectable NSCLC patients candidate to sequential chemo-RT.

Conditions

NSCLC, Stage III

Keywords

durvalumab; radiotherapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Safety

  Incidence of Grade 3 or more possibly related adverse events (PRAEs)

  Within 6 months from study enrollment

Secondary Outcomes (2)

• Progression-Free Survival

  0-36 months from study enrollment

• Overall Survival

  0-36 months from study enrollment

Other Outcomes (1)

• Quality of Life

  0-36 months

Study Arms (1)

Single-arm

EXPERIMENTAL

Chemotherapy plus durvalumab, hypofractionated RT plus durvalumab, durvalumab maintenance

Drug: Durvalumab

Interventions

Durvalumab DRUG

Patients will receive 1500 mg durvalumab via IV infusion q3w concomitant with chemotherapy (Cisplatin/carboplatin plus etoposide) for up to a maximum of 3 cycles, then via IV infusion at the same interval during sequential radiotherapy and then every 4 weeks for up to a maximum of 12 months or until confirmed disease progression, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Also known as: radotherapy, chemotherapy

Single-arm

Eligibility Criteria

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

You may qualify if:

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses.
• Age
• years or older at the time of signing the ICF. Type of patient and disease characteristics
• Histologically- or cytologically-documented NSCLC with locally-advanced, unresectable Stage III disease (according to the IASLC Staging Manual Version 8 \[IASLC 2016\]). Positron emission tomography (PET)/CT, MRI of the brain, and endobronchial ultrasound with biopsy are highly encouraged at diagnosis.
• Patients with measurable disease assessed at baseline by CT/MRI will be entered in this study.
• Must have a life expectancy of at least 12 weeks at enrolment.
• WHO/ECOG PS 0-1.
• Patient not eligible for concurrent chemo radiation according to investigator assessment
• Adequate organ and marrow function at enrollment as defined below. These parameters should be achieved without augmentation by growth factors, transfusions, or infusions within 28 days of screening unless required for SoC:
• Haemoglobin ≥9.0 g/dL;
• Absolute neutrophil count \>1.0 × 109/L;
• Platelet count \>75 × 109/L;
• Serum bilirubin ≤1.5 × upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.

You may not qualify if:

• Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors.
• Mixed small-cell lung cancer and NSCLC histology.
• History of allogeneic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia.
• Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
• Any chronic skin condition that does not require systemic therapy.
• Patients without active disease in the last 5 years at enrolment may be included but only after consultation with the Study Physician.
• Patients with celiac disease controlled by diet alone.
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic GI conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.
• History of another primary malignancy except for:
• Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated carcinoma in situ without evidence of disease.
• History of leptomeningeal carcinomatosis.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Alessandra Ferrari, dr.

CONTACT

+390382503689; alessandra.ferrari@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Model Details: open-label, multi-center, single arm phase 2 trial

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 22, 2021
• Study Start: October 28, 2021
• Primary Completion: November 28, 2024
• Study Completion: November 28, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)