NCT01933932: SELECT-1

Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Active, enrolled Phase 3 Results posted Last updated 19 November 2025

What this trial tests

Phase 3 trial testing Selumetinib in Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV in 510 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

25 September 2013

Primary endpoint
7 June 2016

31 December 2025

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	510
Start date	25 September 2013
Primary completion	7 June 2016
Estimated completion	31 December 2025
Sites	197 locations across Italy, Poland, Netherlands, Russia, Belgium, Sweden, Mexico, Bulgaria

Drugs / interventions tested

• Selumetinib — full drug profile →
• Docetaxel (Docetaxel) — full drug profile →
• Placebo
• Pegylated G-CSF — full drug profile →

Conditions studied

• Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV — all drugs for Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-Free Survival (PFS) Primary · Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)

Group	Value	95% CI
Selumetinib + Docetaxel	3.9	1.5 – 5.9
Placebo + Docetaxel	2.8	1.4 – 5.5

Overall Survival (OS) Secondary · Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI

Overall Survival is defined as the time from the date of randomisation until death due to any cause.

Group	Value	95% CI
Selumetinib + Docetaxel	8.7	3.6 – 16.8
Placebo + Docetaxel	7.9	3.8 – 20.1

Objective Response Rate (ORR) Secondary · Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - \>=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)

Group	Value	95% CI
Selumetinib + Docetaxel	51
Placebo + Docetaxel	35

Duration of Response (DoR) Secondary · Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)

Group	Value	95% CI
Selumetinib + Docetaxel	88.0	82.0 – 126.0
Placebo + Docetaxel	136.0	86.0 – 169.0

Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS) Secondary · Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.

Group	Value	95% CI
Selumetinib + Docetaxel	49
Placebo + Docetaxel	46

Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS) Secondary · Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.

Group	Value	95% CI
Selumetinib + Docetaxel	1.6	0.4 – 4.6
Placebo + Docetaxel	1.3	0.3 – 4.2

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs were collected from the time of signature of informed consent to the main study until 30 days (± 7 days) after the last dose of the last study treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo + Docetaxel

Serious: 82/254 (32%)

Deaths: —

Selumetinib + Docetaxel

Serious: 124/251 (49%)

Deaths: —

Serious adverse events (117 terms)

Reaction	System	Placebo + Docetaxel	Selumetinib + Docetaxel
Pneumonia	Infections and infestations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Sepsis	Infections and infestations	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory tract infection	Infections and infestations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Lower respiratory tract infection	Infections and infestations	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
General physical health deterioration	General disorders	—	—
Lung infection	Infections and infestations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—
Cardiac failure	Cardiac disorders	—	—
Pericardial effusion	Cardiac disorders	—	—
Supraventricular tachycardia	Cardiac disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Colitis	Gastrointestinal disorders	—	—

Other adverse events (572 terms — click to expand)

Reaction	System	Placebo + Docetaxel	Selumetinib + Docetaxel
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Fatigue	General disorders	—	—
Oedema peripheral	General disorders	—	—
Asthenia	General disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Dermatitis acneiform	Skin and subcutaneous tissue disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Dysgeusia	Nervous system disorders	—	—
Neutropenia	Blood and lymphatic system disorders	—	—
Face oedema	General disorders	—	—
Weight decreased	Investigations	—	—
Bone pain	Musculoskeletal and connective tissue disorders	—	—
Paraesthesia	Nervous system disorders	—	—
Lacrimation increased	Eye disorders	—	—
Urinary tract infection	Infections and infestations	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Dizziness	Nervous system disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Paronychia	Infections and infestations	—	—
Oedema	General disorders	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Hypotension	Vascular disorders	—	—

Most-reported serious reactions: Pneumonia, Diarrhoea, Pyrexia, Sepsis, Dyspnoea, Respiratory tract infection, Dehydration, Neutropenia.

Data from ClinicalTrials.gov NCT01933932 adverse events section.

Sponsor's own description

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted therapy for non-small cell lung cancer: current standards and the promise of the future.
   Chan BA, Hughes BG. · · 2015 · cited 538× · PMID 25806345 · DOI 10.3978/j.issn.2218-6751.2014.05.01
2. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial.
   Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, et al · · 2017 · cited 270× · PMID 28492898 · DOI 10.1001/jama.2017.3438
3. KRAS oncogene in non-small cell lung cancer: clinical perspectives on the treatment of an old target.
   Román M, Baraibar I, López I, Nadal E, et al · · 2018 · cited 217× · PMID 29455666 · DOI 10.1186/s12943-018-0789-x
4. Current Development Status of MEK Inhibitors.
   Cheng Y, Tian H. · · 2017 · cited 181× · PMID 28954413 · DOI 10.3390/molecules22101551
5. Emerging strategies to target RAS signaling in human cancer therapy.
   Chen K, Zhang Y, Qian L, Wang P. · · 2021 · cited 164× · PMID 34301278 · DOI 10.1186/s13045-021-01127-w
6. MEK inhibitors for the treatment of non-small cell lung cancer.
   Han J, Liu Y, Yang S, Wu X, et al · · 2021 · cited 154× · PMID 33402199 · DOI 10.1186/s13045-020-01025-7
7. The improbable targeted therapy: KRAS as an emerging target in non-small cell lung cancer (NSCLC).
   Salgia R, Pharaon R, Mambetsariev I, Nam A, et al · · 2021 · cited 109× · PMID 33521700 · DOI 10.1016/j.xcrm.2020.100186
8. Targeting <i>KRAS</i> Mutant Non-Small-Cell Lung Cancer: Past, Present and Future.
   Uras IZ, Moll HP, Casanova E. · · 2020 · cited 109× · PMID 32560574 · DOI 10.3390/ijms21124325