CompletedNCT02789345Updated Feb 5, 2024Results posted

A Study of Ramucirumab (LY3009806) or Necitumumab (LY3012211) Plus Osimertinib in Participants With Lung Cancer

A Phase 1 interventional study of Ramucirumab and Necitumumab in Non-small Cell Lung Cancer, sponsored by Eli Lilly and Company. Completed at 11 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 29
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The main purpose of this study is to evaluate the safety of ramucirumab or necitumumab in combination with osimertinib in participants with non-small cell lung cancer (NSCLC).

Conditions studied

Non-small Cell Lung Cancer

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Keywords

T790M
epidermal growth factor receptor (EGFR)

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 29 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Have a diagnosis of NSCLC with at least 1 measurable lesion assessable using standard techniques by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Have T790M-positive status using a test validated and performed locally after disease progression on EGFR tyrosine kinase inhibitor (TKI) treatment.
Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at the time of enrollment.
Have serum albumin that is ≥25 grams per liter at the time of enrollment.
Have adequate organ function, with all screening labs performed within 7 days of treatment initiation.
Have a life expectancy of ≥3 months.
Have resolution, except where otherwise stated in the inclusion criteria, of all clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1 by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Exclusion criteria

Exclusion Criteria:

Previous treatment with an EGFR monoclonal antibody (except for past treatment for squamous cell carcinoma of head and neck or metastatic colorectal cancer).
Previous treatment with osimertinib or third generation EGFR TKIs.
Participants with symptomatic or growing brain metastases less than 4 weeks prior to enrollment.
History of drug-induced interstitial lung disease (ILD), ILD, or radiation pneumonitis requiring treatment with steroid prior to study enrollment, or any evidence of clinically active ILD.
Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment. Participants with a history of gross hemoptysis (defined as bright red blood of ≥1/2 teaspoon) within 2 months prior to enrollment are excluded.
Have experienced any arterial thrombotic event or arterial thromboembolic event, including myocardial infarction, unstable angina (history or evidence of current clinically relevant coronary artery disease of current ≥Class III as defined by Canadian Cardiovascular Society Angina Grading Scale or congestive heart failure of current ≥Class III as defined by the New York Heart Association), cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
Have a history of deep vein thrombosis, pulmonary embolism, or any other significant venous thromboembolism (venous catheter thrombosis or superficial venous thrombosis not considered "significant") during the 3 months prior to study enrollment. Participants with venous thromboembolism occurring 3 to 6 months prior to study enrollment are allowed, if being treated with low molecular weight heparin.
Have a history of gastrointestinal perforation and/or fistula within 6 months prior to enrollment.
Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
Have uncontrolled hypertension, as defined in CTCAE Version 4.0, prior to initiating study treatment, despite antihypertensive intervention. CTCAE Version 4.0 defines uncontrolled hypertension as Grade >2 hypertension; clinically, the participant continues to experience elevated blood pressure (systolic >160 millimeters of mercury [mmHg] and/or diastolic >100 mmHg) despite medications.
Are receiving chronic therapy with any of the following medications within 7 days prior to enrollment:
- nonsteroidal anti-inflammatory agents (NSAIDs; such as indomethacin, ibuprofen, naproxen, or similar agents).
- other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide).
Have radiologically documented evidence of major blood vessel invasion or encasement by cancer.
Have radiographic evidence of pulmonary intratumor cavitation, regardless of tumor histology.
Are receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy or radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks prior to enrollment.
Have abnormal cardiac findings.
Have undergone chest irradiation within 2 weeks prior to study drug administration, have not recovered from all radiation-related toxicities, or requires corticosteroids. A 2-week washout is permitted for focal palliative radiation to non-central nervous system disease.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 29 participants (actual)

Study arms

Experimental
Arm A: Ramucirumab + Osimertinib
Dose Finding: Participants received Ramucirumab 10 milligrams/kilogram (mg/kg) given intravenously (IV) on day 1 every 2 weeks and osimertinib 80 milligrams (mg) given orally daily during each 14-day cycle.
Drug: Ramucirumab · Drug: Osimertinib
Experimental
Arm B: Necitumumab + Osimertinib
Dose Finding: Participants received Necitumumab 800 mg given IV on days 1 and 8 every 3 weeks and osimertinib 80 mg given orally daily during each 21 day cycle.
Drug: Necitumumab · Drug: Osimertinib
Experimental
Cohort A: Ramucirumab + Osimertinib
Dose Expansion: Participants received Ramucirumab 10 mg/kg given IV on day 1 every 2 weeks and osimertinib 80 mg given orally daily during each 14-day cycle.
Drug: Ramucirumab · Drug: Osimertinib

Interventions

DrugRamucirumab
Administered IV
Also known as: LY3009806
DrugNecitumumab
Administered IV
Also known as: LY3012211
DrugOsimertinib
Administered orally
Also known as: AZD9291

What researchers measure

Primary outcomes

Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)
A Dose Limiting Toxicity (DLT) was defined as one of the following Adverse Events (AE) that is likely related to the study drug or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0: 1. Any nonhematologic Grade ≥3 toxicity, except for toxicities such as liver or renal function abnormality, skin rash that resolves with appropriate therapy, transient hypersensitivity and injection site reactions, myalgia, fatigue, constipation, electrolyte imbalance, nausea, vomiting, diarrhea 2. Hematologic toxicity was considered a DLT as the following: 1. Grade 4 toxicity lasting ≥7 days, or 2. Grade 3 or 4 thrombocytopenia if associated with bleeding or requires platelet transfusion, or 3. Febrile neutropenia 3. Death if considered related to study treatment 4. Any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose limiting
Time frame: Arm A: Cycle 1 through Cycle 2 (14-day cycle); Arm B: Cycle 1 (21-day cycle)

Secondary outcomes

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Cmin was the concentration of study drug in the blood immediately before the next dose was administered.
Time frame: Predose on Day (D) 1 of Cycle (C) 2, Predose on Day 1 of Cycle 4, Predose on Day 1 of Cycle 5, Predose on Day 1 of Cycle 7, Predose on Day 1 of Cycle 13
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Cmin was the concentration of study drug in the blood immediately before the next dose was administered.
Time frame: Predose on Day 1 of Cycle 3, Predose on Day 1 of Cycle 5
Objective Response Rate (ORR) for Ramucirumab in Combination With Osimertinib: Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
ORR was the best overall response of complete response (CR) or partial response (PR) as classified by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR was a disappearance of all target and non-target lesions and normalization of tumor marker level. PR was an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Time frame: Baseline to Objective Disease Progression (up to 25 months)
Disease Control Rate (DCR) for Ramucirumab in Combination With Osimertinib: Percentage of Participants With CR, PR or Stable Disease (SD)
DCR was the best overall response of CR, PR, or SD as defined by RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or one or more new lesions.
Time frame: Baseline to Objective Disease Progression (up to 25 months)
Duration of Response (DoR) for Ramucirumab in Combination With Osimertinib
Duration of Response (DoR) was defined only for participants with a confirmed CR or PR. It was measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date, DOR was censored at the date of the last complete objective progression-free disease assessment.
Time frame: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (up to 25 months)
Progression Free Survival (PFS) for Ramucirumab in Combination With Osimertinib
Progression-free survival (PFS) was the time from the date of first study treatment until the date of radiographic documentation of progression (as defined by RECIST v. 1.1) based on investigator assessment or the date of death due to any cause, whichever was earlier. If a participant did not have a complete baseline disease assessment, then the PFS time was censored at the enrollment date, regardless of whether or not objectively determined disease progression or death was observed for the participant; otherwise, if a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last complete objective progression-free disease assessment date.
Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (up to 26 months)
Overall Survival (OS) for Ramucirumab in Combination With Osimertinib
OS was date of first study treatment until death due to any cause. If the participant was alive at the data inclusion cutoff date for the analysis (or was lost to follow-up), OS was censored on the last date the participant was known to be alive.
Time frame: Baseline to Death from Any Cause (up to 29 months)

Results

Posted Feb 5, 2024

Participant flow

The study consisted of the dose-finding portion (Phase 1a) and the dose-expansion portion (Phase 1b) * Phase 1a, Arm A = combination of ramucirumab and osimertinib; Arm B = combination of necitumumab and osimertinib * Phase 1b included one cohort, the expansion of Arm A with additional participants enrolled i.e., Cohort A, a combination of ramucirumab and osimertinib. Per Protocol, all outcomes for a combination of ramucirumab and osimertinib were analyzed under a single arm i.e., Arm A/Cohort A

Participant flow — Overall Study
Milestone	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib	Cohort A: Ramucirumab + Osimertinib
Started	3	4	22
Received at least one dose of study drug	3	4	22
Completed	0	1	5
Not completed	3	3	17
Withdrew: Adverse event	0	0	1
Withdrew: Death	0	0	1
Withdrew: Physician decision	2	0	1
Withdrew: Progressive disease	1	3	14

Outcome measures

PrimaryPhase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)

A Dose Limiting Toxicity (DLT) was defined as one of the following Adverse Events (AE) that is likely related to the study drug or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE Version 4.0: 1. Any nonhematologic Grade ≥3 toxicity, except for toxicities such as liver or renal function abnormality, skin rash that resolves with appropriate therapy, transient hypersensitivity and injection site reactions, myalgia, fatigue, constipation, electrolyte imbalance, nausea, vomiting, diarrhea 2. Hematologic toxicity was considered a DLT as the following: 1. Grade 4 toxicity lasting ≥7 days, or 2. Grade 3 or 4 thrombocytopenia if associated with bleeding or requires platelet transfusion, or 3. Febrile neutropenia 3. Death if considered related to study treatment 4. Any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose limiting

Time frame:: Arm A: Cycle 1 through Cycle 2 (14-day cycle); Arm B: Cycle 1 (21-day cycle)
Reported as:: Count of participants · Participants

Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)
Participants	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib
Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)	0	0

SecondaryPharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

Cmin was the concentration of study drug in the blood immediately before the next dose was administered.

Time frame:: Predose on Day (D) 1 of Cycle (C) 2, Predose on Day 1 of Cycle 4, Predose on Day 1 of Cycle 5, Predose on Day 1 of Cycle 7, Predose on Day 1 of Cycle 13
Reported as:: Geometric mean · microgram per milliliter (µg/mL)

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
microgram per milliliter (µg/mL)	Arm A/Cohort A: Ramucirumab + Osimertinib
D1C2	41.3 ± 56.3
D1C4	66.7 ± 34.3
D1C5	76.7 ± 27
D1C7	90.7 ± 26.6
D1C13	103 ± 29.6

SecondaryPharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab

Cmin was the concentration of study drug in the blood immediately before the next dose was administered.

Time frame:: Predose on Day 1 of Cycle 3, Predose on Day 1 of Cycle 5
Reported as:: Geometric mean · nanograms per milliliter (ng/mL)

Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
nanograms per milliliter (ng/mL)	Arm B: Necitumumab + Osimertinib
D1C3	NA ± NA
D1C5	NA ± NA

SecondaryObjective Response Rate (ORR) for Ramucirumab in Combination With Osimertinib: Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

ORR was the best overall response of complete response (CR) or partial response (PR) as classified by the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR was a disappearance of all target and non-target lesions and normalization of tumor marker level. PR was an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.

Time frame:: Baseline to Objective Disease Progression (up to 25 months)
Reported as:: Number · Percentage of Participants

Objective Response Rate (ORR) for Ramucirumab in Combination With Osimertinib: Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Percentage of Participants	Arm A/Cohort A: Ramucirumab + Osimertinib
Objective Response Rate (ORR) for Ramucirumab in Combination With Osimertinib: Percentage of Participants With a Complete Response (CR) or Partial Response (PR)	76 (58.1 to 89.0)

SecondaryDisease Control Rate (DCR) for Ramucirumab in Combination With Osimertinib: Percentage of Participants With CR, PR or Stable Disease (SD)

DCR was the best overall response of CR, PR, or SD as defined by RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or one or more new lesions.

Time frame:: Baseline to Objective Disease Progression (up to 25 months)
Reported as:: Number · Percentage of Participants

Disease Control Rate (DCR) for Ramucirumab in Combination With Osimertinib: Percentage of Participants With CR, PR or Stable Disease (SD)
Percentage of Participants	Arm A/Cohort A: Ramucirumab + Osimertinib
Disease Control Rate (DCR) for Ramucirumab in Combination With Osimertinib: Percentage of Participants With CR, PR or Stable Disease (SD)	92 (76.9 to 98.6)

SecondaryDuration of Response (DoR) for Ramucirumab in Combination With Osimertinib

Duration of Response (DoR) was defined only for participants with a confirmed CR or PR. It was measured from the date of first evidence of a confirmed CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date, DOR was censored at the date of the last complete objective progression-free disease assessment.

Time frame:: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (up to 25 months)
Reported as:: Median · Months

Duration of Response (DoR) for Ramucirumab in Combination With Osimertinib
Months	Arm A/Cohort A: Ramucirumab + Osimertinib
Duration of Response (DoR) for Ramucirumab in Combination With Osimertinib	13.37 (9.63 to 21.19)

SecondaryProgression Free Survival (PFS) for Ramucirumab in Combination With Osimertinib

Progression-free survival (PFS) was the time from the date of first study treatment until the date of radiographic documentation of progression (as defined by RECIST v. 1.1) based on investigator assessment or the date of death due to any cause, whichever was earlier. If a participant did not have a complete baseline disease assessment, then the PFS time was censored at the enrollment date, regardless of whether or not objectively determined disease progression or death was observed for the participant; otherwise, if a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last complete objective progression-free disease assessment date.

Time frame:: Baseline to Measured Progressive Disease or Death from Any Cause (up to 26 months)
Reported as:: Median · Months

Progression Free Survival (PFS) for Ramucirumab in Combination With Osimertinib
Months	Arm A/Cohort A: Ramucirumab + Osimertinib
Progression Free Survival (PFS) for Ramucirumab in Combination With Osimertinib	11.04 (5.49 to 19.29)

SecondaryOverall Survival (OS) for Ramucirumab in Combination With Osimertinib

OS was date of first study treatment until death due to any cause. If the participant was alive at the data inclusion cutoff date for the analysis (or was lost to follow-up), OS was censored on the last date the participant was known to be alive.

Time frame:: Baseline to Death from Any Cause (up to 29 months)
Reported as:: Median · Months

Overall Survival (OS) for Ramucirumab in Combination With Osimertinib
Months	Arm A/Cohort A: Ramucirumab + Osimertinib
Overall Survival (OS) for Ramucirumab in Combination With Osimertinib	NA (16.03 to NA)

Adverse events

Collected over Baseline to follow up (5.38 years). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm A: Ramucirumab + Osimertinib	2/3 (66.7%)	1/3 (33.3%)	3/3 (100%)
Arm B: Necitumumab + Osimertinib	1/4 (25%)	1/4 (25%)	4/4 (100%)
Cohort A: Ramucirumab + Osimertinib	11/22 (50%)	8/22 (36.4%)	22/22 (100%)

Most frequent serious events

Showing 10 of 17

Most frequent serious events
Event	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib	Cohort A: Ramucirumab + Osimertinib
DiverticulitisInfections and infestations	1/3	0/4	0/22
Abdominal pain upperGastrointestinal disorders	0/3	1/4	0/22
PyrexiaGeneral disorders	0/3	0/4	3/22
PneumoniaInfections and infestations	0/3	0/4	2/22
ThrombocytopeniaBlood and lymphatic system disorders	0/3	0/4	1/22
Atrioventricular block second degreeCardiac disorders	0/3	0/4	1/22
Cardiac failure congestiveCardiac disorders	0/3	0/4	1/22
Intestinal obstructionGastrointestinal disorders	0/3	0/4	1/22
Pancreatitis acuteGastrointestinal disorders	0/3	0/4	1/22
Cystitis klebsiellaInfections and infestations	0/3	0/4	1/22

Most frequent other events

Showing 10 of 188

Most frequent other events
Event	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib	Cohort A: Ramucirumab + Osimertinib
DiarrhoeaGastrointestinal disorders	3/3	4/4	14/22
CoughRespiratory, thoracic and mediastinal disorders	3/3	0/4	6/22
FatigueGeneral disorders	0/3	3/4	3/22
Dry skinSkin and subcutaneous tissue disorders	1/3	3/4	2/22
PyrexiaGeneral disorders	2/3	1/4	3/22
ArthralgiaMusculoskeletal and connective tissue disorders	2/3	1/4	4/22
HypertensionVascular disorders	1/3	0/4	14/22
NauseaGastrointestinal disorders	1/3	2/4	8/22
Decreased appetiteMetabolism and nutrition disorders	1/3	2/4	9/22
Dermatitis acneiformSkin and subcutaneous tissue disorders	1/3	2/4	0/22

Baseline characteristics

All enrolled participants

Age, Categorical
Age, Categorical(Participants)	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib	Cohort A: Ramucirumab + Osimertinib	Total
<=18 years	0	0	0	0
Between 18 and 65 years	2	2	12	16
>=65 years	1	2	10	13

Sex: Female, Male
Sex: Female, Male(Participants)	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib	Cohort A: Ramucirumab + Osimertinib	Total
Female	1	3	17	21
Male	2	1	5	8

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib	Cohort A: Ramucirumab + Osimertinib	Total
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	3	4	22	29
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib	Cohort A: Ramucirumab + Osimertinib	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	13	13
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	3	4	9	16
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Arm A: Ramucirumab + Osimertinib	Arm B: Necitumumab + Osimertinib	Cohort A: Ramucirumab + Osimertinib	Total
South Korea	0	0	6	6
United States	1	1	3	5
Taiwan	0	0	5	5
France	0	1	0	1
Spain	2	2	8	12

Study locations

11 sites

Memorial Sloan Kettering Cancer Center
New York, New York 10065, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Villejuif, 94805, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cheong Ju-City, 28644, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seongnam, 13496, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, 05505, Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, 06351, Korea, Republic of
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid, 28041, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sevilla, 41013, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Tainan, 70403, Taiwan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Taipei city, 10002, Taiwan

References and documents

Publications

Yu HA, Paz-Ares LG, Yang JC, Lee KH, Garrido P, Park K, Kim JH, Lee DH, Mao H, Wijayawardana SR, Gao L, Hozak RR, Chao BH, Planchard D. Phase I Study of the Efficacy and Safety of Ramucirumab in Combination with Osimertinib in Advanced T790M-positive EGFR-mutant Non-small Cell Lung Cancer. Clin Cancer Res. 2021 Feb 15;27(4):992-1002. doi: 10.1158/1078-0432.CCR-20-1690. Epub 2020 Oct 12. PubMed 33046516 ↗

Study documents

Study protocol · Mar 28, 2018
Statistical analysis plan · Dec 6, 2017

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02789345
Lead sponsor: Eli Lilly and Company
Collaborators: AstraZeneca
Responsible party: Sponsor
First posted: Jun 3, 2016
Start date: Oct 24, 2016
Primary completion: Oct 19, 2017
Completion: May 9, 2022
Results posted: Feb 5, 2024
Last update: Feb 5, 2024

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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