IO102 with pembrolizumab, with or without chemotherapy for NSCLC
Research type
Research Study
Full title
An Open-label, Randomized, Phase I/II Trial Investigating the Safety and Efficacy of IO102 in Combination with Pembrolizumab, with or without \nChemotherapy, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer
IRAS ID
250126
Contact name
James Spicer
Contact email
Sponsor organisation
IO Biotech Aps
Eudract number
2018-000139-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 22 days
Research summary
The purpose of this trial is to investigate the safety and efficacy of the combination of IO102 and standard treatment (pembrolizumab with or without chemotherapy) compared to the standard treatment alone.\n\nThere will be 2 phases of the research trial and 2 treatment groups depending on the characteristics of the patient’s cancer cells. The first phase of the trial will determine if the addition of the trial drug to anti-cancer standard treatment increases side effects (safety). The second phase of the trial will determine if the addition of the trial drug to anti-cancer standard treatment stabilises or reduces the size of the patient’s tumour(s) (efficacy).\n\nTrial treatment will be given for approximately 2 years; however, the length of the patient’s participation will depend on whether they are tolerating the trial drug or if they are responding to treatment. It is estimated that approximately 108 patients will participate in this research trial.
Summary of study results:
This was a Phase I/II, multi-center, international, open-label, randomized trial investigating the safety and efficacy of IO102 and pembrolizumab combination with or without chemotherapy in patients with metastatic non-small cell lung cancer who had not received prior anti-cancer treatment therapy for their metastatic disease. The trial was conducted in Spain, Germany, Netherlands, and the United Kingdom.
The trial had two separate portions, known as phases, each of which had different objectives. The primary objective of the Phase I portion was to investigate the safety of IO102 and pembrolizumab combination with or without chemotherapy. The primary objective of the Phase II portion of the trial was to assess the efficacy of IO102 and pembrolizumab combination with or without chemotherapy, measured by the objective response rate in patients with metastatic non-small cell lung cancer.
The trial enrolled its first patient on 19 September 2018. In the Phase I portion of the trial, 6 patients received IO102 with pembrolizumab and 6 patients received IO102 with pembrolizumab and chemotherapy. Seven of the 12 patients (58.3%) were male and 5 (41.7%) were female, and the median age of Phase I patients was 61 years. In the Phase II portion of the trial, 32 patients received IO102 with pembrolizumab, 33 patients received IO102 with pembrolizumab and chemotherapy, 16 patients received pembrolizumab alone, and 16 patients received pembrolizumab and chemotherapy. Sixty-five patients (66.3%) were male, and 33 patients (33.7%) were female, and the median age of patients was 65 years. All of the patients had discontinued treatment as of 30 June 2022.
The combination of IO102 and pembrolizumab with or without chemotherapy was found to be well tolerated, and the addition of IO102 to the standard treatment regimens did not affect their efficacy.
An overall response rate in patients treated with IO102 in combination with pembrolizumab was 47.4% compared to 43.8% in patients treated with pembrolizumab alone. An overall response rate in patients treated with IO102 in combination with pembrolizumab and chemotherapy was 39.4% compared to 52.9% in patients treated with pembrolizumab and chemotherapy.
The addition of IO102 to the standard treatment regimens was associated with predominantly moderate IO102-related side effects, particularly injection related reactions. The rate of serious adverse events was comparable in patients receiving IO102 and pembrolizumab with or without chemotherapy (42.4 and 40.6%, respectively), as well as in patients receiving pembrolizumab with or without chemotherapy (56.3 and 31.3%, respectively).REC name
London - South East Research Ethics Committee
REC reference
18/LO/1483
Date of REC Opinion
28 Sep 2018
REC opinion
Favourable Opinion