10 reasons to choose

Proven PFS in Del 19 and L858R based on two large-scale global trials1,2

FOR 1ST-LINE EGFR M+ mNSCLC VS CHEMOTHERAPY

Median progression-free survival (PFS) in LUX- Lung 3

*LUX-Lung 3: GILOTRIF 40 mg orally once daily (n=230) vs up to 6 cycles of pemetrexed/cisplatin (n=115) as 1st-line therapy in patients with EGFR M+ mNSCLC; primary endpoint was PFS; key secondary endpoint was OS; LUX-Lung 6: GILOTRIF 40 mg orally once daily (n=242) vs up to 6 cycles of gemcitabine/cisplatin (n=122) as 1st-line therapy in patients with EGFR M+ mNSCLC; primary endpoint was PFS; key secondary endpoint was OS.

Subanalysis of primary endpoint; measured by an independent central radiology review.

M+ mNSCLC=mutation-positive metastatic NSCLC; HR=hazard ratio; CI=confidence interval.

Del 19 Patient Profile, Download PDF
Del 19 Patient Profile Download PDF
L858R Patient Profile, Download PDF
L858R Patient Profile Download PDF

Only agent with proven overall survival (OS) in Del 191,2,5

FOR 1ST-LINE EGFR M+ mNSCLC VS CHEMOTHERAPY

Median overall survival (OS) in LUX-Lung 3

An approved treatment option for patients with L858R mutations1,2

  • 27.6 months for afatinib (n=91) vs 40.3 months for pemetrexed-cisplatin (n=47);
    HR 1.30 [95% CI, 0.80-2.11]

Established safety profile based on >4200 patients in clinical trials1

Adverse reactions reported in LUX-Lung 3 in ≥10% of
GILOTRIF-treated patients1

Adverse reaction GILOTRIF (n=229) Pemetrexed/
cisplatin (n=111)
GILOTRIF (n=229) Pemetrexed/
cisplatin (n=111)
Grade 3a, % Grade 3a, % All grades, % All grades, %

Gastrointestinal disorders

Diarrhea

Stomatitisb

Cheilitis

15

9

0

2

1

0

96

71

12

23

15

1

Skin and subcutaneous tissue disorders

Rash/acneiform dermatitisc

Pruritus

Dry skin

16

0

0

0

0

0

90

21

31

11

1

2

Infections

Paronychiad

Cystitis

11

1

0

0

58

13

0

5

Respiratory, thoracic, and mediastinal disorders

Epistaxis

Rhinorrhea

0

0

1

0

17

11

2

6

Investigations

Weight decreased

1

1

17

14

General disorders and administration site conditions

Pyrexia

0

0

12

6

Eye disorders

Conjunctivitis

0

0

11

3

Other clinically important adverse reactions observed in patients treated with GILOTRIF include: decreased appetite (29%), nausea (25%), and vomiting (23%)1

aNone of the adverse reactions in this table except stomatitis (1 patient on GILOTRIF [0.4%]) were grade 4 in severity.

bIncludes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion, mucosal ulceration.

cIncludes acne, acne pustular, dermatitis, acneiform dermatitis, dermatosis, drug eruption, erythema, exfoliative rash, folliculitis, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculo-papular, rash pruritic, rash pustular, skin disorder, skin erosion, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer.

dIncludes paronychia, nail infection, nail bed infection.

Serious adverse reactions (ARs) and discontinuations1

SERIOUS ADVERSE REACTIONS REPORTED IN LUX-LUNG 31

  • Serious adverse reactions were reported in 29% of patients treated GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal adverse reactions in GILOTRIF-treated patients included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%) and pneumonia (0.43%)

DISCONTINUATIONS IN LUX-LUNG 3

  • Discontinuation of therapy in GILOTRIF-treated patients for adverse reactions was 14%1
  • The most frequent adverse reactions that led to discontinuation in GILOTRIF-treated patients were diarrhea (1.3%), ILD (0.9%), and paronychia (0.9%)1

Significantly improved survival vs erlotinib1

IN ADVANCED SqCC OF THE LUNG PROGRESSING AFTER CHEMOTHERAPY*

*In LUX-Lung 8, a head-to-head trial vs erlotinib in patients with metastatic squamous cell carcinoma (SqCC) of the lung with disease progression following ≥4 cycles of platinum-based chemotherapy; primary endpoint was PFS; key secondary endpoint was OS.

Median PFS: 2.4 months with afatinib vs 1.9 months with erlotinib
(HR: 0.82; 95% CI, 0.68-0.99)1

Only oral agent approved in SqCC regardless of mutation status6

NO BIOMARKER TESTING REQUIRED6

LUX-Lung 8: Disease control was improved with afatinib (51%) vs
erlotinib (40%)6†

Disease control (complete response, partial response, stable disease, non-complete response, and non-progressive disease) was a secondary endpoint of LUX-Lung 8. Excluding patients with non-complete response and non-progressive disease, disease control with afatinib was 37%, vs 29% with erlotinib, in a post hoc analysis.6

Similar occurrence of serious ARs vs erlotinib1,6

IN ADVANCED SqCC OF THE LUNG (LUX-LUNG 8)

SERIOUS ADVERSE REACTIONS REPORTED IN LUX-LUNG 81

  • Serious adverse reactions occurred in 44% of patients treated with GILOTRIF. The most frequent serious adverse reactions in patients treated with GILOTRIF were pneunomia (6.6%), diarrhea (4.6%), and dehydration and dyspnea (3.1% each). Fatal adverse reactions in GILOTRIF-treated patients included ILD (0.5%), pneumonia (0.3%), respiratory failure (0.3%), acute renal failure (0.3%), and general physical health deterioration (0.3%).

DISCONTINUATION IN LUX-LUNG 8

  • Treatment-related discontinuation due to any adverse reaction was similar in both arms (20% vs 17% for GILOTRIF vs erlotinib)6
  • The most frequent adverse reactions that led to discontinuation in GILOTRIF-treated patients were diarrhea (4.1%) and rash/acne (2.6%)1

Adverse reactions (≥10%) reported in LUX-Lung 81

Adverse reaction GILOTRIF (n=392) Erlotinib (n=395) GILOTRIF (n=392) Erlotinib (n=395)
Grade
3-4, %
Grade
3-4, %
All grades, % All grades, %

Gastrointestinal disorders

Diarrhea

Stomatitisa

Nausea

Vomiting

11

4

2

1

3

1

1

1

75

30

21

13

41

11

16

10

Skin and subcutaneous tissue disorders

Rash/acneiform dermatitisb

Pruritus

7

0

11

0

70

10

70

13

Infections

Paronychiac

1

0

11

5

Metabolism and nutrition disorders

Decreased appetite

3

2

25

26

aIncludes stomatitis, aphthous stomatitis, mucosal inflammation, mouth ulceration, oral mucosa erosion, mucosal erosion,
mucosal ulceration.

bIncludes acne, dermatitis, acneiform dermatitis, eczema, erythema, exfoliative rash, folliculitis, rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, rash pustular, skin exfoliation, skin fissures, skin lesion, skin reaction, skin toxicity, skin ulcer.

cIncludes paronychia, nail infection, nail bed infection.

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Dose adjustment reduced the frequency and severity of ARs7

IN A POST HOC ANALYSIS OF LUX-LUNG 3

LUX-Lung 3: Over half of patients reduced dose1,4

percentages
  • The most frequent adverse reactions that led to dose reduction in the patients treated with GILOTRIF were diarrhea (20%), rash/acne (19%), stomatitis (10%), and paronychia (14%)1

PFS results were consistent among patients with or without dose adjustments, based on a post hoc analysis of LUX-Lung 37

Data from intention-to-treat population, which includes both patients with common and uncommon EGFR mutations.

Dose adjustment can be an important strategy to help manage ARs1,3

Initiate therapy at the recommended 40-mg dose*
Evaluate patients for adverse reactions within 2 weeks and periodically thereafter
Pause
  • treatment for ≥ grade 3 adverse reactions
  • or ≥ grade 2
    • diarrhea (prolonged)a,b
    • cutaneous reactions (prolonged or intolerable)a,c
    • renal impairment
Resume treatment at 10 mg less per day when adverse reaction fully resolves, returns to baseline, or improves to grade 1

*In patients with severe renal impairment, the recommended dose of GILOTRIF is 30 mg orally once daily.

aNational Cancer Institute Common Terminology Criteria for Adverse Events, v4.03.

bGrade ≥2 diarrhea persisting ≥48 hours while taking antidiarrheal medication.

cGrade 2 cutaneous reactions >7 days.

Permanently discontinue GILOTRIF for1:

Life-threatening bullous, blistering, or exfoliative skin lesions; confirmed ILD; severe drug-induced hepatic impairment; persistent ulcerative keratitis; symptomatic left ventricular dysfunction; and severe or intolerable adverse reaction occurring at a dose of 20 mg per day.

GILOTRIF Dose Exchange facilitates transition to a new dose

Eliminates additional GILOTRIF co-pay in a given month for eligible patients

Eligible patients receive a new dose of GILOTRIF—prepaid mailer will accompany newly prescribed dose, allowing for the convenient return of unused tablets from prior dose

Call 1-877-814-3915 to learn more about the program

GILOTRIF Dose Exchange™ covers up to 2 dose modifications for patients serviced through Accredo® or GILOTRIF Dispensing Network who have 9 or more tablets to exchange.

Patient selection

  • Select patients for the 1st-line treatment of mNSCLC with GILOTRIF based on the presence of Del 19 or L858R mutations in tumor specimens
  • Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics

Advise your patients on GILOTRIF dosing1

  • The recommended dose is 40 mg orally once daily
  • In patients with severe renal impairment, the recommended dose of GILOTRIF is 30 mg orally once daily*

*Estimated glomerular filtration rate [eGFR] 15 to 29 mL/min/1.73 m2.

Advise your patients on how GILOTRIF should be taken1

  • At least 1 hour before or 2 hours after a meal
  • Not to take a missed dose within 12 hours of the next dose

Treatment Duration1

  • Treatment should be continued until disease progression or until no longer tolerated by the patient

Multiple strengths1

  • Multiple tablet strengths available to assist your patients with dose adjustment
GILOTRIF Tablet Multiple Strengths
GILOTRIF Prescription and Enrollment Form, Download PDF
GILOTRIF Prescription and Enrollment Form Download PDF

Call 1-877-814-3915 to learn more about the program

GILOTRIF is unlikely to affect the metabolism of other drugs that are substrates CYP450 enzymes, or be impacted by the use of PPIs1,8

DRUG-DRUG INTERACTIONS

  • GILOTRIF is unlikely to affect the metabolism of other drugs that are substrates of CYP450 enzymes1
  • GILOTRIF is unlikely to be impacted by the use of proton pump inhibitors (PPIs)8

EFFECT OF P-GLYCOPROTEIN (P-GP) INHIBITORS AND INDUCERS1

  • P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) can increase exposure to GILOTRIF
  • P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John's wort) can decrease exposure to GILOTRIF

FOR PATIENTS WHO REQUIRE THERAPY WITH A P-GP INHIBITOR OR INDUCER1

  • P-gp inhibitors
    • Reduce GILOTRIF daily dose by 10 mg if not tolerated. Resume the previous dose after discontinuation of the P-gp inhibitor as tolerated
  • P-gp inducers
    • Increase GILOTRIF daily dose by 10 mg as tolerated. Resume the previous dose 2 to 3 days after discontinuation of the P-gp inducer

CYP450=cytochrome P450.

GILOTRIF: Well established, well studied in over 4200 patients1

LUX-Lung 3: Largest global trial in EGFR M+ mNSCLC to date5

  • Randomized, multicenter, open-label trial that assessed the safety and efficacy of GILOTRIF 40 mg orally once daily (n=230) vs up to 6 cycles of pemetrexed/cisplatin (n=115) as 1st-line therapy in patients with EGFR M+ mNSCLC1
  • Primary endpoint was PFS; key secondary endpoint was OS3

Majority of patients in LUX-Lung 3 had Del 19 or L858R EGFR mutations1,3,9:

Patient Mutations in LUX-Lung 3

Efficacy information in uncommon mutations in LUX-Lung 3 (n=37)1

  • There were 26 GILOTRIF-treated patients in the “other” (uncommon) EGFR mutations subgroup, which consisted of 9 unique mutation patterns1
  • Median PFS: 2.8 months with GILOTRIF vs 9.9 months with pemetrexed/cisplatin (HR: 1.89; 95% CI, 0.84-4.28)1,10
  • Median OS: 15.9 months with GILOTRIF vs 40.8 months with pemetrexed/cisplatin (HR: 2.35; 95% CI, 0.96-6.11)1,4

LUX-Lung 6: Largest trial in Asian EGFR M+ NSCLC patients11

  • Randomized, multinational, prospective, phase III trial that assessed the safety and efficacy of GILOTRIF 40 mg orally once daily (n=242) vs up to 6 cycles of gemcitabine/cisplatin (n=122) as 1st-line therapy in patients with EGFR M+ mNSCLC
  • Primary endpoint was PFS

LUX-Lung 8: Head to head vs erlotinib in patients with metastatic SqCC6

  • Randomized, multicenter, open-label phase III trial that assessed the safety and efficacy of GILOTRIF 40 mg orally once daily (n=398)
    vs erlotinib 150 mg once daily (n=397) in patients with metastatic squamous NSCLC with disease progression following ≥4 cycles of platinum-based chemotherapy
  • Primary endpoint was PFS; key secondary endpoint was OS
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IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Diarrhea
  • GILOTRIF can cause diarrhea which may be severe and can result in dehydration with or without renal impairment. In clinical studies, some of these cases were fatal.
  • For patients who develop Grade 2 diarrhea lasting more than 48 hours or Grade 3 or greater diarrhea, withhold GILOTRIF until diarrhea resolves to Grade 1 or less, and then resume at a reduced dose.
  • Provide patients with an anti-diarrheal agent (e.g., loperamide) for self-administration at the onset of diarrhea and instruct patients to continue anti-diarrheal until loose stools cease for 12 hours.
Bullous and Exfoliative Skin Disorders
  • GILOTRIF can result in cutaneous reactions consisting of rash, erythema, and acneiform rash. In addition, palmar-plantar erythrodysesthesia syndrome was observed in clinical trials in patients taking GILOTRIF.
  • Discontinue GILOTRIF in patients who develop life-threatening bullous, blistering, or exfoliating lesions. For patients who develop Grade 2 cutaneous adverse reactions lasting more than 7 days, intolerable Grade 2, or Grade 3 cutaneous reactions, withhold GILOTRIF. When the adverse reaction resolves to Grade 1 or less, resume GILOTRIF with appropriate dose reduction.
  • Postmarketing cases of toxic epidermal necrolysis (TEN) and Stevens Johnson syndrome (SJS) have been reported in patients receiving GILOTRIF. Discontinue GILOTRIF if TEN or SJS is suspected.
Interstitial Lung Disease
  • Interstitial Lung Disease (ILD) or ILD-like adverse reactions (e.g., lung infiltration, pneumonitis, acute respiratory distress syndrome, or alveolitis allergic) occurred in patients receiving GILOTRIF in clinical trials. In some cases, ILD was fatal. The incidence of ILD appeared to be higher in Asian patients as compared to white patients.
  • Withhold GILOTRIF during evaluation of patients with suspected ILD, and discontinue GILOTRIF in patients with confirmed ILD.
Hepatic Toxicity
  • Hepatic toxicity as evidenced by liver function tests abnormalities has been observed in patients taking GILOTRIF. In 4257 patients who received GILOTRIF across clinical trials, 9.7% had liver test abnormalities, of which 0.2% were fatal.
  • Obtain periodic liver testing in patients during treatment with GILOTRIF. Withhold GILOTRIF in patients who develop worsening of liver function. Treatment should be discontinued in patients who develop severe hepatic impairment while taking GILOTRIF.
Keratitis
  • Keratitis has been reported in patients taking GILOTRIF.
  • Withhold GILOTRIF during evaluation of patients with suspected keratitis. If diagnosis of ulcerative keratitis is confirmed, treatment with GILOTRIF should be interrupted or discontinued. If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered. GILOTRIF should be used with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration.
Embryo-Fetal Toxicity
  • GILOTRIF can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
  • Advise females of reproductive potential to use effective contraception during treatment, and for at least 2 weeks after the last dose of GILOTRIF. Advise female patients to contact their healthcare provider with a known or suspected pregnancy.

ADVERSE REACTIONS

Adverse Reactions observed in clinical trials were as follows:
First-line treatment of EGFR mutation-positive, metastatic non-small cell lung cancer (NSCLC)
  • In GILOTRIF-treated patients (n=229) the most common adverse reactions (≥20% all grades & vs pemetrexed/cisplatin-treated patients (n=111)) were diarrhea (96% vs 23%), rash/acneiform dermatitis (90% vs 11%), stomatitis (71% vs 15%), paronychia (58% vs 0%), dry skin (31% vs 2%), and pruritus (21% vs 1%). Other clinically important adverse reactions observed in patients treated with GILOTRIF include: decreased appetite (29%), nausea (25%), and vomiting (23%).
  • Serious adverse reactions were reported in 29% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each). Fatal adverse reactions in GILOTRIF-treated patients included pulmonary toxicity/ILD-like adverse reactions (1.3%), sepsis (0.43%), and pneumonia (0.43%).
  • More GILOTRIF-treated patients (2.2%) experienced ventricular dysfunction (defined as diastolic dysfunction, left ventricular dysfunction, or ventricular dilation; all < Grade 3) compared to chemotherapy-treated patients (0.9%).
Previously Treated Metastatic Squamous NSCLC
  • In GILOTRIF-treated patients (n=392) the most common adverse reactions (≥20% all grades & vs erlotinib-treated patients (n=395)) were diarrhea (75% vs 41%), rash/acneiform dermatitis (70% vs 70%), stomatitis (30% vs 11%), decreased appetite (25% vs 26%), and nausea (21% vs 16%).
  • Serious adverse reactions were reported in 44% of patients treated with GILOTRIF. The most frequent serious adverse reactions reported in patients treated with GILOTRIF were pneumonia (6.6%), diarrhea (4.6%); and dehydration and dyspnea (3.1% each). Fatal adverse reactions in GILOTRIF-treated patients included ILD (0.5%), pneumonia (0.3%), respiratory failure (0.3%), acute renal failure (0.3%), and general physical health deterioration (0.3%).
Postmarketing Experience

Pancreatitis has been reported during post-marketing use of GILOTRIF. The frequency and causal relationship of pancreatitis to GILOTRIF has not been established.

DRUG INTERACTIONS

Effect of P-glycoprotein (P-gp) Inhibitors and Inducers
  • Concomitant use of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib.
  • Concomitant use of P-gp inducers (including but not limited to rifampicin, carbamazepine, phenytoin, phenobarbital, and St. John’s wort) with GILOTRIF can decrease exposure to afatinib.

USE IN SPECIFIC POPULATIONS

Lactation
  • Because of the potential for serious adverse reactions in nursing infants from GILOTRIF, lactating women should not breastfeed during treatment with GILOTRIF and for 2 weeks after the final dose.
Females and Males of Reproductive Potential
  • GILOTRIF may reduce fertility in females and males of reproductive potential. It is not known if the effects on fertility are reversible.
Renal Impairment
  • Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] 15 to 29 mL/min /1.73 m2) have a higher exposure to afatinib than patients with normal renal function. Administer GILOTRIF at a starting dose of 30 mg once daily in patients with severe renal impairment. GILOTRIF has not been studied in patients with eGFR <15 mL/min/1.73 m2 or who are on dialysis.
Hepatic Impairment
  • GILOTRIF has not been studied in patients with severe (Child Pugh C) hepatic impairment. Closely monitor patients with severe hepatic impairment and adjust GILOTRIF dose if not tolerated.

INDICATIONS AND USAGE

  • GILOTRIF (afatinib) is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

    Limitation of Use: Safety and efficacy of GILOTRIF have not been established in patients whose tumors have other EGFR mutations.
  • GILOTRIF is indicated for the treatment of patients with metastatic squamous NSCLC progressing after platinum-based chemotherapy.

GF PROF ISI July 2016

References: 1. Gilotrif® (afatinib) tablets Prescribing Information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. 2. Yang JC-H, Wu Y-L, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16(2):141-151. 3. Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327-3334. 4. Data on file. Boehringer Ingelheim. CTR. 5. Lee CK, Wu YL, Ding PN, et al. Impact of specific epidermal growth factor receptor (EGFR) mutations and clinical characteristics on outcomes after treatment with EGFR tyrosine kinase inhibitors versus chemotherapy in EGFR-mutant lung cancer: a meta-analysis. J Clin Oncol. 2015;33(17):1958-1965. 6. Soria J-C, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015;16:897-907. 7. Yang JC, Sequist LV, Zhou C, et al. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials [published online September 6, 2016]. Ann Oncol. 2016. doi: 10.1093/annonc/mdw322. 8. Peters S, Zimmermann S, Adjei AA. Oral epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non-small cell lung cancer: comparative pharmacokinetics and drug-drug interactions. Cancer Treat Rev. 2014;40(8):917-926. 9. Sharma SV, Bell DW, Settleman J, Haber DA. Epidermal growth factor receptor mutations in lung cancer. Nat Rev Cancer. 2007;7(3):169-181. 10. Data on file. Boehringer Ingelheim. Other mutations PFS table. 11. Wu YL, Zhou C, Hu CP, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(2):213-222.

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