Dinutuximab and Irinotecan versus Irinotecan effect in treatment of unresponsive Small Cell Lung Cancer patients

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/12/011012
• Date of registration: 28-12-2017
• Prospective Registration: Yes
• Primary sponsor: United Therapeutics
• Public title: Dinutuximab and Irinotecan versus Irinotecan effect in treatment of unresponsive Small Cell Lung Cancer patients
• Scientific title: A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
• Date of first enrolment: 01-01-2018
• Target sample size: 470
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21434
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 2/ Phase 3

Countries of recruitment

Australia, Bulgaria, Canada, France, Georgia, Germany, Hong Kong, Hungary, India, Italy, Lithuania, Malaysia, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States of America

Contacts

• Name: Odette K Jordan
• Affiliation: United Therapeutics

• Name: Lokesh Chaudhari
• Affiliation: United Therapeutics

Key inclusion & exclusion criteria

Inclusion criteria: 1.Have histologically or cytologically confirmed SCLC (undifferentiated small-cell carcinoma arising in or consistent with lung cancer origin).

2.Documented relapse or disease progression during or after first-line platinum-based therapy (subjects refractory to initial platinum-based therapy are eligible).

3.Have no curative therapy available.

4.Have a life expectancy of at least 12 weeks.

5.Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

6.Have adequate bone marrow and hepatic function.

7.Have calculated creatinine clearance (CrCL) >=30 mL/minute or serum creatinine <=1.5 times below the upper limit of normal.

8.Women of reproductive potential must not be pregnant or breastfeeding and have a negative urine or serum pregnancy test obtained within 7 days prior to the first dose of study treatment.

9.Subjects must agree to consistently use 2 forms of highly effective contraception/birth control between signing of the informed consent and 60 days after the last study drug administration.


Exclusion criteria: 1.Candidate for re-treatment with original platinum-based regimen as second-line therapy.

2.Prior treatment with irinotecan, topotecan, or dinutuximab.

3.Have active brain metastases. Subjects with brain metastases are allowed if they completed definitive brain therapy, are asymptomatic and radiologically stable, and if they are not currently receiving corticosteroids or radiation.

4.Have mixed small cell and non-small cell histologic features.

5.Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated <3 years ago.

6.Have a history or current evidence of uncontrolled cardiovascular disease.

7.Have had a major surgery or significant trauma within 4 weeks of enrollment (Part 1) or randomization (Part 2).

8.Have had organ allograft or hematopoietic transplantation.

9.Have a history of hypersensitivity to any study drugs or their excipients, or intolerance to hydration due to preexisting pulmonary or cardiac impairment, or intolerance to opioid pain medications, or a history of severe hypersensitivity to any other antigen.

10.Have a history or current evidence of human immunodeficiency virus (HIV) infection.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Small Cell Lung Cancer

Intervention(s)

Intervention1: Dinutuximab: Dinutuximab injection, for intravenous (IV) use
Control Intervention1: Irinotecan
: Irinotecan injection, IV infusion

Control Intervention2: Topotecan: Topotecan for injection

Primary Outcome(s)

Overall survival (OS)Timepoint: [Time Frame: Up to approximately 2.5 years]

Secondary Outcome(s)

Progression-free survival (PFS)

Objective response rate (ORR)

Clinical benefit rate (CBR)

Area under the concentration versus time curve (AUC) of dinutuximab

Maximum concentration (Cmax) of dinutuximab

Halt-life (t1/2) of dinutuximab

Clearance (CL) of dinutuximab

Incidence of adverse events

Incidence of toxicitiesTimepoint: 1. Up to approximately 2.5 years

2. Up to approximately 2.5 years

3. Up to approximately 2.5 years

4. Approximately 4 months

5. Approximately 4 months

6. Approximately 4 months

7. Approximately 4 months

8. Up to approximately 2.5 years

9. Up to approximately 2.5 years

Secondary ID(s)

NIL

Source(s) of Monetary Support

United Therapeutics 1040 Spring Street Silver Spring, Maryland 20910 USA

Ethics review

Status: Approved
Approval date: 28/06/2017
Contact:

Institution Ethics Committee, Bhagwan Mahaveer Cancer Hospital and Research Centre, Jawaharlal Nehru Marg, Jaipur- 302017, Rajasthan

Status: Approved
Approval date: 14/07/2017
Contact:

Institutional Ethics Committee Poona medical research foundation, Ruby Hall Service Clinic, E4-C2 E4F, 5th Avenue, Condominium, Soraj Building, 4th Floor, Dhole Patil Road, Pune- 4110001, Maharashtra, India

Status: Approved
Approval date: 30/08/2017
Contact:

Jaslok Hospital and Research Center Ethics Committee, 6th floor, Jaslok Hospital & Research Center ,15, Dr. G Deshmukh Marg,Mumbai 400026, Maharashtra, India

Status: Approved
Approval date: 18/09/2017
Contact:

Institutional Ethics Committee (IEC), KLE University, JN Medical College, Nehru Nagar, Belagavi 590010, Karnataka, India

Status: Approved
Approval date: 19/10/2017
Contact:

Office of the Ethics Committee, SMS Medical College and Attached Hospital,Dhanwantri OPD,SMS Hospital, Jaipur, Rajasthan, India

Status: Approved
Approval date: 30/11/2017
Contact:

Office of Ethics Committee, SMS Medical College Hospital Jaipur

Status: Approved
Approval date: 21/12/2017
Contact:

Institution Ethics Committee, Deenanath Mangeshkar Hospital & Research Centre Pune 411004

Status: Approved
Approval date: 22/11/2019
Contact:

Sri Venkateshwara Hospital Ethics Committee, 27, 29 Main Road Rashtra Kuvempu, Nagara, BTM 2nd Stage, BTM Layout, Bangalore 560076

Results

• Date Completed: 21/02/2020