Clinical Trials

16/009 ILLUMINATE

ILLUMINATE A Phase 2 trial of durvalumab (MEDI4736) and tremelimumab with chemotherapy in metastatic EGFR mutant non-squamous non-small cell lung cancer (NSCLC) following progression on EGFR Tyrosine Kinase Inhibitors (TKIs)

Recruitment target:
100
(Australia- 50 patients; Taiwan- 50 patients)
Status:
In Follow-up
(Closed to recruitment in Australia: 18/11/21)

Summary:

ILLUMINATE evaluated the efficacy and tolerability of immunotherapy (durvalumab and tremelimumab) with platinum-pemetrexed chemotherapy in patients with metastatic EGFR-mutant NSCLC (T790M+ve or T790M-ve) who had progressed following prior EGFR TKI therapy. At the time the ILLUMINATE study commenced, the role of immunotherapy for patients with EGFR+ NSCLC that had progressed on a third generation TKI was unclear. Various studies suggested benefit, but differed in whether immunotherapy was delivered as monotherapy, as a dual immunotherapy combination or together with chemotherapy.

Clinical trial design:

Open-label Phase II clinical trial with two treatment cohorts (T790M+ve and T790M-ve)

Indication:

Relapsed NSCLC with EGFR mutation of Exon 19 deletion or Exon 21 L858R point mutation and either (i) no evidence of T790M or (ii) T790M and progression on a 3rd generation TKI. Note that patients treated with > 2 lines of prior EGFR TKI or immunotherapy with checkpoint inhibitors are excluded from the study.

Intervention:

Four 3 weekly cycles of induction chemotherapy and immunotherapy (durvalumab and tremelimumab), followed by 4 weekly maintenance therapy of pemetrexed and durvalumab.

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