AZD2811 and Durvalumab (MEDI4736) Combination Therapy in Relapsed Small Cell Lung Cancer

Conditions

• SCLC, Recurrent

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab+AZD2811 to SCLC patients — DRUG
  AZD2811 must NOT be infused through a 0.2-µm or 0.22-µm filter and therefore durvalumab and AZD2811 MUST be infused through different infusion lines. In order not to exceed the endotoxin limit, durvalumab and AZD2811 mustbe administered consecutively. Durvalumab is administered first over 1 hour, followed by AZD2811 administered over 2 hours. AZD2811 should be administered at 30 minutes after the end of the durvalumab infusion, as long as there are no acute infusion reactions to durvalumab.

Study Details

Samsung Medical Centre, Seoul, Korea. Additional 0\~5 Korea Lung Cancer Consortium (KLCC) centres in Korea Up to 40 subjects will be enrolled in two-stages (first stage: 19 evaluable subjects and second stage: 17 evaluable subjects and additional 4 subjects considering the drop out rate) If the study is conducted as de-escalated dosage (Durvalumab 1120mg) after the safety run-in, number of the patients will be counted from the second safety-run in phase.

Key Dates

Start date

Sep 18, 2020

Status verified

Feb 2022

Primary completion

Jan 14, 2022

Completion

Jan 14, 2022

Study Design

Enrollment

4 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab+AZD2811 to SCLC patients
  Dosage and Schedule: AZD2811 500mg and durvalumab 1500mg via IV administered on Day 1 for every 3weeks (fixed dosing for subjects \> 30 kg body weight for durvalumab). One cycle is consisted of 3 weeks. The drug products must be dosed consecutively using different infusion lines. The sequence of infusions is as follows: durvalumab is administered first over 1 hour, followed by AZD2811 administered over 2 hours. A waiting time interval of at least 30 minutes between the end of durvalumab infusion and start of AZD2811 infusion should be adhered to.

Primary Outcome Measure

Disease control rate is defined as the proportion of patients with best response of CR, PR, or who have SD for at least 12 weeks [ Time Frame: 12 weeks ]