Clinical trial NCT01139775 (phase 1/phase 2, status: completed)
Conditions: non small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: pemetrexed, cisplatin, ly2603618
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H], [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, CC1=NC=C(NC(=O)NC2=C(OC[C@@H]3CNCCO3)C=C(C)C(Br)=C2)N=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Phase 1 portion:

               -  Participants with a cytologic or histologic diagnosis of nonsquamous NSCLC that
                  is classified as Stage IV according to the 7th edition of the American Joint
                  Committee on Cancer (AJCC) classification and for whom the combination of
                  pemetrexed and cisplatin is deemed to be appropriate

               -  Participants with histologic or cytologic diagnosis of malignant mesothelioma
                  that is unresectable

               -  Participants with histologic or cytologic diagnoses of advanced or metastatic
                  solid tumors who are not candidates for any standard therapy and for whom the
                  combination with pemetrexed and cisplatin is deemed to be appropriate

          -  Phase 2 portion:

               -  Have a histological diagnosis of NSCLC other than predominantly squamous cell
                  histology that is classified as Stage IV according to the 7th edition of the AJCC
                  classification

               -  Eligible for a first line of palliative treatment with a platinum doublet

               -  Have archived or fresh tumor tissue (not cytology)

          -  Phase 1 participants can have measurable or nonmeasurable disease. Phase 2
             participants must have at least 1 measurable lesion according to Investigational New
             Drug (Response Evaluation Criteria in Solid Tumors [RECIST], v1.1) definitions. Tumor
             lesions located in a previously irradiated area can be considered measurable if they
             are new or if have shown unequivocal progression.

          -  Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale

          -  Have adequate hematologic, hepatic, and renal organ function

          -  Prior radiation therapy for treatment of cancer is allowed to <25% of the bone marrow,
             and participants must have recovered from the acute toxic effects of their treatment
             prior to study enrollment. Prior radiation to the whole pelvis is not allowed. Prior
             radiotherapy must be completed at least 4 weeks before study entry

          -  For women: Must be surgically sterile, postmenopausal, or compliant with a highly
             reliable contraceptive method (failure rate <1%) during and for 6 months after the
             treatment period; must have a negative serum or urine pregnancy test within 7 days
             before study enrollment and must not be breast-feeding. For men: Must be surgically
             sterile or compliant with a contraceptive regimen during and for 6 months after the
             treatment period

        Exclusion Criteria:

          -  Have serious preexisting medical conditions or serious concomitant systemic disorders
             that would compromise the safety of the participant or his/her ability to complete the
             study, at the discretion of the investigator (for example, unstable angina pectoris or
             uncontrolled diabetes mellitus). Special attention should be paid to kidney and heart
             conditions that may be worsened with cisplatin treatment or hydration

          -  Have central nervous system (CNS) metastases (unless the participant has completed
             successful local therapy for CNS metastases and has been off corticosteroids for at
             least 4 weeks before starting study therapy). A screening computed tomography scan or
             magnetic resonance imaging before enrollment in the absence of a clinical suspicion of
             brain metastases is not required.

          -  Have current active infection that would, in the opinion of the investigator,
             compromise the participant's ability to tolerate therapy

          -  Have known allergy to pemetrexed, cisplatin, LY2603618, or any ingredient of
             pemetrexed, cisplatin, or LY2603618

          -  Have clinically significant (by physical exam) third-space fluid collections; for
             example, ascites or pleural effusions that cannot be controlled by drainage or other
             procedures prior to study entry

          -  Participants taking non-steroidal anti-inflammatory drugs who cannot interrupt the
             treatment appropriately according to the guidelines

          -  Have received a recent yellow-fever vaccination (within 28 days of enrollment) or are
             receiving concurrent yellow-fever vaccination

          -  Phase 1 portion:

               -  Have received more than 2 previous lines of chemotherapy for the
                  advanced/metastatic disease

               -  Have received more than 6 cycles of therapy containing an alkylating agent