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Intensified Chemo-immuno-radiotherapy With Durvalumab for Stage III Non-Small Cell Lung Cancers

CompletedPhase 2

Sponsor: Latin American Cooperative Oncology Group

Conditions: Lung Neoplasms

Interventions: Durvalumab

Countries: Brazil

This is a phase II study that will assess if Durvalumab (MEDI4736) used as induction chemo-immunotherapy followed by concurrent chemo-immuno-radiotherapy and consolidation immunotherapy may improve oncologic outcomes compared with standard of care chemoradiation followed by durvalumab (as in the PACIFIC trial) with a reasonable safety profile.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

INCLUSION CRITERIA

1. Histologically or cytologically confirmed non-small cell lung cancer.
2. Stage III according to the American Joint Committee on Cancer (AJCC) Staging Manual, 8th edition.
3. No prior systemic therapy, radiation therapy, or surgery for the current cancer.
4. Age ≥ 18 years at time of study entry
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Body weight \>30kg
7. Pre- or post-bronchodilator forced expiratory volume 1 ≥ 1.2 litres/second or ≥ 50% of predicted value
8. Adequate normal organ and marrow function

EXCLUSION CRITERIA

1. Patients whose radiation treatment is likely to encompass a volume of whole lung receiving ≥ 20 Gy in total of more than 35% of lung volume.
2. Patients whose radiation treatment is likely to deliver a cardiac dose V50 \> 25%
3. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
4. Participation in another clinical study with an investigational product with anti-neoplastic activity during the last 3 weeks prior to treatment initiation
5. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
6. History of allogenic organ transplantation.
7. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
8. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
9. Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
10. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 antibodies
11. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
12. Prior radiation therapy to the region of the study cancer that would result in overlap of radiation therapy fields.
13. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of the investigational product.
14. Active or prior documented autoimmune or inflammatory disorders
15. Uncontrolled intercurrent illness
16. History of another primary malignancy
17. Known active infection including tuberculosis , hepatitis B, hepatitis C, or human immunodeficiency virus.

Locations (6)

Rio de Janeiro, Rio de Janeiro, Brazil
Natal, Rio Grande do Norte, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Rio de Janeiro, Brazil
São Paulo, Brazil
São Paulo, Brazil