Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Cisplatin

Immunomodulating Agents

Durvalumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)

Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29

Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1

Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36

Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36

1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).

Radiation

Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.

Surgical Resection

Greg A Durm, MD

This is an open label, multi-institutional, single arm Phase II trial. All patients will be treated with Carboplatin, Paclitaxel, Durvalumab and Radiation. All patients with non-PD after induction therapy who remain surgical candidates will undergo surgical resection 4-12 weeks following induction therapy.

After surgical resection, all patients who remain eligible will be treated with adjuvant Durvalumab every 4 weeks for 6 cycles beginning 4-12 weeks after surgical resection.

Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer

A Phase II Study of Concurrent Chemoradiation Plus Durvalumab (MEDI4736) Followed by Surgery Followed by Adjuvant Durvalumab (MEDI4736) in Medically Operable Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer

Pathologic Complete Response Rate is defined as lack of evidence of viable cancer in the surgical specimen at the time of surgery.

Pathologic N0 rate is defined as a lack of evidence of viable cancer in the removed lymph nodes at the time of surgery.

Adverse events, \>= grade 3 and related to treatment will be summarized by frequency and severity according to the NCI Common Terminology Criteria for (NCI CTCAE) v5

Disease free survival will be defined as the time from surgical resection until the criteria for disease recurrence is met or death as a result of any cause. Disease recurrence is return of the cancer to where it started (local) or in another part of the body (distant).

AstraZeneca

Indiana University School of Medicine

Greg Durm, MD

Sponsor-Investigator

Neoadjuvant chemotherapy(Durvalumab, Paclitaxel, Carboplatin), radiation and immunotherapy (durvalumab) followed by surgical resection followed by adjuvant immunotherapy (durvalumab)

Durvalumab: Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29

Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1

Paclitaxel: Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36

Carboplatin: Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36

Radiation: 1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).

Surgical Resection: Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.

Treatment

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction, 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, and 5=Dead

Baseline ECOG

Fauzia Sharmin

Pathological Complete Response Achieved

Pathological Complete Response Not Achieved

4 Subjects completed the surgical procedure and were evaluable for Pathologic Complete Response

Pathologic Complete Response Rate

Pathologic N0 Status Achieved

Pathologic N0 Status Not Achieved

4 subjects completed the surgical procedure and were evaluable for Pathologic N0 status

Pathologic N0 Rate

LUNG INFECTION Grade 5

HYPOKALEMIA Grade 4

ACIDOSIS Grade 3

APPENDICITIS Grade 3

PAIN Grade 3

Assess Adverse Events (AE)

4 patients out of 6 are evaluable for DFS. 2 patients did not go through the surgery and no response was recorded.

Spots Global Cancer Trial Database for Chemoradiation Plus Durvalumab Followed by Surgery Followed by Adjuvant Durvalumab in Patients With Surgically Resectable Stage III (N2) Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial