A Dose Escalation Study of L-DOS47 in Recurrent or Metastatic Non-Squamous NSCLC

It is planned that patients will receive 4 cycles of combination treatment with L-DOS47 +
pemetrexed/carboplatin. Patients who have not progressed following the 4 cycles of
combination treatment and who have not experienced unacceptable toxicity will have the
opportunity to continue to receive L-DOS47 treatment for as long as there is clinical benefit
and it is well-tolerated, in the opinion of the Investigator, until disease progression.
Patients who are unable to complete 4 cycles of L-DOS47 + pemetrexed/carboplatin combination
treatment due to pemetrexed/carboplatin toxicity will have the opportunity to continue
receiving L-DOS47 treatment following discontinuation of pemetrexed/carboplatin, for as long
as there is clinical benefit and it is well-tolerated, in the opinion of the Investigator,
until disease progression.

Main Inclusion Criteria:

1. Male or female patient ≥ 18 years of age

2. Histologically or cytologically confirmed non-squamous NSCLC

3. EGFR-mutation positive patients must have progressed on or had intolerance to an EGFR
small molecule tyrosine kinase inhibitor

4. Patients whose tumors harbor an anaplastic lymphoma kinase (ALK) translocation must
have progressed on or had intolerance to an ALK inhibitor;

5. No prior adjuvant chemotherapy within 1 year of the first treatment day if there is
recurrent disease

6. At least 1 site of measurable disease per Response Evaluation Criteria in Solid Tumors
(RECIST) v1.1

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and minimum
life expectancy of ≥ 3 months

8. Adequate bone marrow, renal and liver function

Main Exclusion Criteria:

1. Histologic evidence of predominantly squamous cell NSCLC

2. Brain metastasis and/or leptomeningeal disease (known or suspected)

3. Peripheral neuropathy > CTCAE grade 1

4. Possibility of a curative local treatment (surgery and/or radiotherapy)

5. Previous chemotherapy except adjuvant treatment with progression of disease documented
≥ 12 months after end of adjuvant treatment

6. Having received treatment in another clinical study within the 30 days prior to
commencing study treatment or having side effects of a prior study drug that are not
recovered to grade ≤ 1 or baseline, except for alopecia

7. Concurrent chronic systemic immunotherapy, chemotherapy or hormone therapy